FDA RRAs: Navigating FDA’s Alternative Oversight Tools, May WLW

RRAs: Navigating FDA’s Alternative Oversight Tools

The FDA’s use of Remote Regulatory Assessments (RRAs) and Remote Interactive Evaluations (RIEs) has fundamentally changed how regulated companies are monitored and many organizations still underestimate the regulatory impact. During our recent Warning Letter Wednesday webinar, we explored how RRAs and RIEs are evolving from temporary pandemic-era tools into permanent components of FDA oversight strategy.

What Is an FDA Remote Regulatory Assessment (RRA)?

An RRA is a remote examination of an FDA-regulated establishment and/or its records used to evaluate compliance with applicable FDA requirements. Unlike a traditional on-site inspection, RRAs are conducted remotely and can include:

• Remote record reviews
• Written responses to FDA questions
• Video walkthroughs
• Livestreaming sessions
• Conference calls and virtual meetings

The FDA emphasizes that RRAs are not inspections under Section 704(a)(1) of the FD&C Act. However, they are still used to support regulatory decision-making. In practical terms:

“Not an inspection, but definitely a review with inspection-level consequences.”

Watch the full webinar here:

Why FDA Uses RRAs

RRAs allow the FDA to:

• Assess compliance remotely & review CAPA effectiveness
• Evaluate manufacturing processes & support application decisions
• Determine whether an on-site inspection is necessary & investigate unresolved quality concerns

The FDA can also use RRAs to prioritize or accelerate future inspections, especially if the assessment reveals potential systemic quality issues.

The Industry Misconception: “It’s Only Remote”

One of the most important points discussed during the webinar was how many companies mistakenly treat RRAs as lower-risk interactions. That assumption is dangerous!

While RRAs do not typically involve FDA-482s or FDA-483s, companies are still expected to provide timely, accurate, and complete responses. The agency may issue extensive records requests, ask formal written questions, and conduct detailed discussions with site personnel.

Most importantly, RRAs can:

• Lead to Warning Letters
• Contribute to Complete Response Letters (CRLs)
• Trigger follow-up inspections

Real-World Example: Unomedical Device Warning Letter

The webinar highlighted the January 2026 Warning Letter issued to Unomedical Device in Reynosa, Mexico. What made this case especially significant was that:

• No FDA investigator was physically on-site
• The agency conducted the review remotely
• The assessment relied heavily on records requests and written responses

Despite the absence of a traditional inspection, the FDA still identified major Quality System Regulation (QSR) and Medical Device Reporting (MDR) concerns.

According to the Warning Letter timeline:

• FDA records requests began in May and June 2025
• The RRA occurred between July and August 2025
• The company submitted three responses to the FDA, which were deemed inadequate
• A Warning Letter was issued in January 2026

Key Trends in FDA Remote Oversight

The webinar also reviewed FDA RRA activity trends from 2022 through 2024. Some notable observations included:

• Peak RRA activity occurred in July 2022
• FDA completed more than 680 RRAs during the reporting period analyzed
• Activity has stabilized but continues regularly
• While the volume may fluctuate, remote assessments are clearly now embedded - within FDA’s long-term compliance framework.

How Companies Should Prepare

Organizations should approach RRAs with the same seriousness and structure used for inspections. Best practices discussed during the webinar included:

1. Build RRA Readiness Into Existing Inspection Programs

Companies should update inspection readiness SOPs to specifically address: Remote document management Virtual meeting protocols FDA communication workflows Response timelines Escalation procedures

2. Train Personnel Before an RRA Happens

Teams must understand:

• How RRAs work
• What FDA expects
• How to respond during virtual interactions
• How written responses may be interpreted by regulators

3. Focus on “Right First Time” Responses

Incomplete or poorly structured responses create credibility risks. Every submission should be:

• Accurate
• Organized
• Complete
• Evidence-based
• Reviewed internally before submission

4. Treat Every RRA Like an Enforcement Opportunity

Companies should avoid assuming that remote means informal. The FDA may use RRA findings to:

• Escalate oversight
• Support enforcement actions
• Schedule follow-up inspections
• Evaluate pending applications

The Bigger Compliance Shift

One of the broader themes from the webinar was that FDA oversight is becoming increasingly data-driven, continuous, and technology-enabled. This means companies must maintain inspection readiness at all times, not just when investigators arrive on-site. Today, the agency can evaluate firms remotely using:

• Records requests
• Digital evidence
• Complaint trending
• CAPA documentation
• Virtual facility interactions

Final Takeaway

The FDA’s remote oversight tools are no longer experimental. RRAs and RIEs are now established regulatory mechanisms capable of producing serious compliance and enforcement outcomes. For regulated companies, the lesson is straightforward:

If your organization would struggle during an RRA, it will likely struggle during a full inspection as well.

Strong quality systems, disciplined documentation practices, and proactive inspection readiness remain the foundation of successful FDA compliance management. As regulatory oversight continues evolving, organizations that prepare early and respond strategically will be in the strongest position to reduce risk and maintain credibility with the agency.

Transcript

Starting in May 2026 we will be adding the full transcript for both agents and viewers of this content.

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ligia zubik: Pharma.

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ligia zubik: Okay, later.

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Daniel Barreto: Yeah, okay, perfect.

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Zephaniah Odidika: Sorry about the technical difficulties. We can get started now.

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Daniel Barreto: So, if you don't mind putting the presentation.

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Zephaniah Odidika: Yes.

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Zephaniah Odidika: So yes, thank you, everybody, for… for joining One Letter Wednesday.

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Zephaniah Odidika: We are here with Daniel Barreto, ex-FDA investigator. My name is FNI Odinica, co-founder of GKS.

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Zephaniah Odidika: And today, we're going to talk about RRAs and RIEs, navigating FDA's alternative oversight tools.

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Zephaniah Odidika: I'm gonna give it off to Dan to give us an introduction.

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Zephaniah Odidika: Thank you, Dan.

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Daniel Barreto: Well, I guess, I mean, a simple introduction to myself. As all of you know, or most of you know, I'm a former FDA investigator, and I've also worked with the pharmaceutical industry.

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Daniel Barreto: Between FDA and the industry for over 45 years. Currently I'm the president and owner of

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Daniel Barreto: my own consulting company, PharmQ Global Consulting, and I am a senior advisor for GKS on the Kpedia platform, which is an important, tool right now for the entire industry, so…

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Daniel Barreto: What we want to do today, is to talk about

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Daniel Barreto: Seth, I'm not able to,

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Daniel Barreto: Move the slides, can you move to the next slide, please?

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Daniel Barreto: So, so today we, we want to talk about, remote regulatory assessments, and

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Daniel Barreto: The reason why I wanted to do this with the network that we're working with on a month-to-month basis through these seminars is because I recently had the opportunity to actually do some technical support for a client in Europe.

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Daniel Barreto: Who, was the subject of a remote regulatory assessment. In this case.

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Daniel Barreto: The client received, a formal request from the FDA with a number of questions about

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Daniel Barreto: Characteristics of the product,

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Daniel Barreto: The activities associated with it that had to do with technical testing, had to do with production activities, etc.

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Daniel Barreto: And in this case, the client was supposed to put together a formal response to each and every one of those questions.

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Daniel Barreto: The client was also expected to provide a certain number of documents.

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Daniel Barreto: To the FDA. And this being the first time my client was subjected to a remote regulatory assessment.

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Daniel Barreto: I think that for them, it's important to accomplish two things. One is to really understand what was the…

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Daniel Barreto: Principle associated with, the meaning and the relevance of a remote regulatory assessment?

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Daniel Barreto: And the second thing was, okay, the FDA is making this request.

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Daniel Barreto: what do we do about it? How do we present to the FDA

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Daniel Barreto: A response that it's gonna have a…

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Daniel Barreto: the intended objective that the FDA has.

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Daniel Barreto: And I think that the client did the right thing, in terms of accessing, you know, our services and our support, because when you think of, you know, regulatory, remote regulatory assessments, you…

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Daniel Barreto: The first thing that people tell you is, It's not an inspection, so…

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Daniel Barreto: So it gives everybody the impression that because an assessment is not an inspection, maybe this evaluation that the FDA is having, it doesn't have the same weight, it doesn't have the same relevance as an inspection would have.

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Daniel Barreto: And I… and what I want to say is there's nothing further from the truth. Sorry, so this is not correct.

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Daniel Barreto: there is a lot of relevance associated with this, and this is why we are going to be discussing this in a few minutes.

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Daniel Barreto: It's not an inspection, it's a review. However, what you need to understand, it's really, what is it that the FDA is going to do with the information they actually access?

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Daniel Barreto: From these, remote regulatory assessments. So, the definition is

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Daniel Barreto: That is an examination, it's a review.

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Daniel Barreto: Of… of a company, of its records.

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Daniel Barreto: And it's conducted entirely remotely, so it doesn't really… Mean…

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Daniel Barreto: or involves an FDA inspector coming to your site. But they… that still is intended to evaluate

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Daniel Barreto: compliance of your activities, or specific activities, to applicable FDA requirements. So the word compliance here is extremely important, because what that means is that this is serious business to the FDA.

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Daniel Barreto: And so, why is it that the FDA is now getting into these regulatory assessments that are remote?

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Daniel Barreto: And the reason for that is… is… is based on a number of factors. One is.

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Daniel Barreto: The volume of work that the FDA has to do, it's immense.

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Daniel Barreto: The FDA is using a risk-based approach to assessing and monitoring the industry.

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Daniel Barreto: And also, the FDA doesn't always have all the resources that it needs, so it's found an alternative way to figure out

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Daniel Barreto: where is it that the FDA has to put its own efforts, right? So now, the key components associated with the remote regulatory assessment

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Daniel Barreto: It involves a review of records, so this… so… so when the FDA is asking you for records.

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Daniel Barreto: That means they're gonna review them, they're gonna reach them, they're gonna look for…

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Daniel Barreto: Strengths and weaknesses associated with those records, so don't believe that

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Daniel Barreto: Because they ask you to fill out a questionnaire, basically.

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Daniel Barreto: And that they will not take the time or put the effort into reviewing those records. So… so the accuracy, the precision.

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Daniel Barreto: of those records, and sending the right records to the FDA is something that you have to keep in mind.

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Daniel Barreto: The other component is what the FDA calls a remote interactive evaluation, RIE, and in many cases, or in most of the cases, the… these…

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Daniel Barreto: remote, remote interactive evaluations are voluntary in nature, because the FDA is, in these cases, is looking at

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Daniel Barreto: Activities that… for which it had a certain level of interest, but… but not necessarily

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Daniel Barreto: the level of intent that they have is as high as what they would have for a remote regulatory system, but

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Daniel Barreto: Nonetheless, listen.

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Daniel Barreto: Whether they call it a remote interactive evaluation, or a remote?

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Daniel Barreto: regulatory assessment. The FDA is collecting data.

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Daniel Barreto: from you, The FDA is evaluating data from you.

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Daniel Barreto: And the FDA will make decisions with respect to the data that it evaluates from you. So… so I think that…

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Daniel Barreto: When it comes to these activities, Do not just be… Extremely complacent or comfortable.

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Daniel Barreto: It's not an inspection.

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Daniel Barreto: According to the law. And part of that is because

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Daniel Barreto: For it to be an inspection?

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Daniel Barreto: An inspector would have to go to your site, they would have to issue a notice of inspection to you, so they would have to have follow-up formality. So, in the law.

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Daniel Barreto: Remote regulatory assessments are not even defined or considered, so… so what the law says is that for this to be an inspection.

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Daniel Barreto: It has to be according to the law. So the FDA, in its wisdom, came up with this concept of regulatory assessments that are remote.

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Daniel Barreto: But when you look at the outcomes from these, they're really not that different, in many cases, from what you would expect from an inspection. So I think it's important for everybody to understand the remote regulatory assessment is serious business to the FDA.

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Daniel Barreto: Next slide.

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Daniel Barreto: So, what are some of the common tools that the FDA uses to oversee, to monitor the industry? So, you know the inspection, right? So, you could have a pre-approval inspection in which case, what the FDA is going to do is to look at two things that are important to them. One is.

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Daniel Barreto: Any activities associated with the product, it's under pre-approval, inspection, and then the systems that support that pre-approval product.

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Daniel Barreto: So it's more of a targeted inspection, but of course, it also looks… it looks into your system. So, that is an inspection.

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Daniel Barreto: If you get a warning letter, and… because of an inspection.

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Daniel Barreto: then, more than likely, the FDA is going to do a follow-up inspection to that warning letter. And then, of course.

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Daniel Barreto: by statutory requirement, the FDA is supposed to perform, routine, inspections,

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Daniel Barreto: Typically, every 2 years for the pharmaceutical industry.

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Daniel Barreto: And, and this is just, again, another form of inspecting. Now.

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Daniel Barreto: To oversee, there's the issuance of the 483, which, if you get a 483, that triggers a warning letter, potentially, but the first thing that it triggers is a response from you, which is also evidence development for the agency.

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Daniel Barreto: The warning letter itself

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Daniel Barreto: It's also a tool that the FDA uses to keep track of your level of compliance. Complete response letters.

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Daniel Barreto: for cost inspections. Now.

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Daniel Barreto: There is also another tool that you really don't want to deal with, which is a criminal investigation, because

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Daniel Barreto: That's not a GMP inspection, but it's really more of an inspection that is intended to look at your… the integrity.

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Daniel Barreto: of your activities, and it has… you're not gonna get a warning letter from this, you're just gonna get a different level of enforcement, which is more criminal in nature.

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Daniel Barreto: And then, from now on, the FDA is talking about

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Daniel Barreto: remote regulatory assessments, so… so that toolbox from the FDA, it's… it's increasing. And we all need to get,

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Daniel Barreto: let's say, used to all of this, and as you recall, even about 2 weeks ago, the departing commissioner from the FDA spoke about a concept called one-day inspections, which, by the way.

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Daniel Barreto: I mean, for most of us,

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Daniel Barreto: I want to see exactly how these activities are going to take place, because honestly.

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Daniel Barreto: I just don't see how… A company could be inspected within one day, and…

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Daniel Barreto: And for an inspector to be able to really do a very serious assessment. So, maybe for some companies that are extremely compliant, that this may work, but again, I think what, in the end, all of this is about a risk-based approach that the FDA is using.

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Daniel Barreto: So next slide, please.

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Daniel Barreto: So, key phrases that, that, that are important to, to this, it's, it's, again, it's…

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Daniel Barreto: Regular remote interactive evaluation, where the agency actually could even also do conference calls, video conferences with you.

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Daniel Barreto: And then remote records review, where the agency just looks at records, and they may or may not require these conferences. But I want to say something about the, the video conferences.

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Daniel Barreto: Because keep in mind that,

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Daniel Barreto: These video conferences, yes, they are not inspections, but again, they are another, form.

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Daniel Barreto: Of evidence development for the agency.

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Daniel Barreto: So, you really need to make sure that your subject matter experts are actually Prepared, knowledgeable. So, when you…

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Daniel Barreto: get an invite from the FDA that they want to do a video conference with you, you really have to make sure that the people who will be

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Daniel Barreto: speaking with the FDA through this video conference, these are the right people, that they are prepared, that they have the right documents in place.

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Daniel Barreto: Some people have asked me, Should I have a back room?

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Daniel Barreto: Prepare for a remote regulatory assessment, especially if one involves the,

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Daniel Barreto: The use of video conferences? And my response is, absolutely.

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Daniel Barreto: Absolutely. Assume for a moment that a remote regulatory assessment could take the worst turn

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Daniel Barreto: that you did not expect, and it's something for which you have to be prepared. Which, by the way.

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Daniel Barreto: Wikipedia is an important source of information for this type of activity. So, one of the things that… that I want to recommend is that

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Daniel Barreto: If you have not subscribed to Wikipedia, that you consider doing so. Oh, 99% of my presentation here

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Daniel Barreto: was supported, by information that I was able to gather from Q-Poppedia. And it's interesting how QPedia

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Daniel Barreto: provides excellent feedback, instant feedback, on how, you know, regulatory assessments are performed. Let's go to the next slide, please.

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Daniel Barreto: So, what do they…

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Daniel Barreto: seek to accomplish these regulatory assessments. First, it's a compliance assessment. It's on your product.

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Daniel Barreto: Or products, it's on your process, or processes.

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Daniel Barreto: And… and what the FDA also wants to know is.

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Daniel Barreto: Let's say you got a 483 citation.

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Daniel Barreto: And it didn't step up to a warning letter. But let's say it even stepped up to a warning letter. The FDA now wants to know, do I want to do an inspection, a follow-up inspection, or do I want to do an assessment and find out

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Daniel Barreto: If the company has done the right implementation of CAPS. So, so you need to see all of this as an opportunity, or as a potential threat. And let me tell you what I mean by this.

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Daniel Barreto: If you pass your regulatory assessment, correctly.

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Daniel Barreto: there is a high possibility that the FDA will bypass

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Daniel Barreto: performing an on-site inspection of your facility. So this is a great thing for you to

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Daniel Barreto: for you to consider, because if it happens this way, you've done your job. So the opposite is also true. If you don't do a good regulatory.

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Daniel Barreto: Assessment response.

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Daniel Barreto: there is a high possibility that the FDA will consider coming to do an inspection. So… so they are… they're going to be looking at your corrective action from previous inspections, etc.

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Daniel Barreto: And now, the FDA can also make decisions related to applications. So, let's say you have a pending approval for a product.

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Daniel Barreto: And then the FDA, instead of considering

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Daniel Barreto: Another inspection, because let's say they did an inspection last year, and everything went well.

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Daniel Barreto: with that inspection. And if he doesn't want to repeat another inspection within a year, which is something that you have to keep in mind, this is a good thing.

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Daniel Barreto: then, then use this as an opportunity to, to avoid the need for a pre-approval inspection. So… so they're going to be looking at some pre-approval work.

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Daniel Barreto: They're gonna identify some unreported adverse events, so… or incomplete corrective actions, so… so what I'm proposing to you is that

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Daniel Barreto: Make sure that, Your corrective action program is complete.

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Daniel Barreto: it's well under control, because this is an area, this is a low-hanging fruit area, where the FDA is going to say.

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Daniel Barreto: Okay, if we were to do… and I'm thinking, like, a one-day inspection remote, right?

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Daniel Barreto: So, a supervisory investigator may say, do we need to do this inspection? Well, let's call this company

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Daniel Barreto: And let's collect information

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Daniel Barreto: about the status of their adverse events, their corrective action program, their investigations. Let's take a look at 5, 6 investigations.

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Daniel Barreto: And let's see, was the investigation performed correctly? Did they have… did they have the right root cause in place? Did they implement the right Kappa?

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Daniel Barreto: Yeah, exactly. They do exactly what they were supposed to do. Okay, that's a good signal. Let's… let's reschedule that, or postpone that inspection for… by 6 months, or whatever.

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Daniel Barreto: So this is the sort of thing that could happen.

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Daniel Barreto: The opposite is also going to be true.

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Daniel Barreto: But because you really missed Doing the right thing?

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Daniel Barreto: now the FDA is going to be compelled to come and do an inspection of your site. Let's go to the next…

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Daniel Barreto: Slide, please.

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Daniel Barreto: So, the duration of a remote regulatory assessment usually lasts a week, but it could be shorter or longer.

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Daniel Barreto: And this is where, if it's shorter, more than likely you're doing the right thing. If it's longer, it means that

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Daniel Barreto: Either the information that you're giving them is incomplete.

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Daniel Barreto: Or the information that you're giving them is giving them now a reason to want to obtain more information.

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Daniel Barreto: Now, elements to the… that you should watch for. Why me, and why now? So, there is always a reason why the FDA wants to do a regulatory assessment.

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Daniel Barreto: And what I want to say is that…

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Daniel Barreto: If you get a remote regulatory assessment from the FDA, an invitation, I want to see that as a good signal. I want to see that as a positive signal. Because what that means is that the FDA is seriously considering that more than likely, you're doing something right, and they just want to verify.

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Daniel Barreto: So, so don't see the regulatory, remote regulatory assessment as something bad.

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Daniel Barreto: unless you're not doing the right thing, and then you already know, but this is something that you need to. Now, the second thing that is important is what's the theme of the regulatory… remote regulatory assessment?

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Daniel Barreto: In the case of my client that I was working with, it was with respect to certain activities that had to do with the way

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Daniel Barreto: that product was protected from a containing closure system perspective. So the FDA was interested in understanding

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Daniel Barreto: Was that… is that container closure system well designed? Was it well validated? So when I was working with my client, I said, you really need to make sure that the FDA gets a pretty good understanding that that container closure system

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Daniel Barreto: It's… it's exactly what the FDA should be comfortable with. So, given the right data, showing the right… that you did the right validation, showing that you did the right stability work, etc, etc.

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Daniel Barreto: Now, the other thing is, how many questions am I getting?

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Daniel Barreto: Right? So… so the number and type of questions are you getting, it's going to give you a good idea as to where is it that the FDA is trying to go with it.

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Daniel Barreto: And then, of course, think of the type of interaction that EFT is proposing. If it's only remote records requests versus remote interviews.

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Daniel Barreto: For interviews, you know, on conference calls, I would be, more concerned?

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Daniel Barreto: About making sure that the subject matter experts are prepared.

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Daniel Barreto: that I have a front room there that is facilitating the process.

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Daniel Barreto: that I would deal with that conversation, not as a casual conversation.

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Daniel Barreto: You are dealing with the agency.

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Daniel Barreto: Under an official capacity, so you need to make sure that you're covering that.

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Daniel Barreto: Let's go to the… by the way, Seth, or George, or… do we have any questions so far?

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Daniel Barreto: Right, from anybody?

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Zephaniah Odidika: No questions, no questions yet.

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Daniel Barreto: No question. Perfect. So let's go to the next slide.

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Daniel Barreto: So, so how do… how do they, you know, differentiate from inspection? Are they considered inspection? We already said no. But when you look at the elements associated with what happens during a regulatory assessment.

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Daniel Barreto: I would say, well.

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Daniel Barreto: Yeah, by definition, it's not an inspection, but the steps that are taken by the FDA.

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Daniel Barreto: are basically similar to what they would do during an inspection. And for those of you who are present here, and those of you who will be listening on YouTube.

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Daniel Barreto: My suggestion is that not only you become familiar with

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Daniel Barreto: the guidance documents that the FDA is putting together for remote regulatory assessment, but please type this,

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Daniel Barreto: document number. It's called SMG6001.1. It's a staff manual guide.

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Daniel Barreto: from the FDA, because it gives you a very specific information about exactly how the entire MMA process and RIA process goes through.

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Daniel Barreto: And, it also talks about how,

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Daniel Barreto: these assessments are classified, so you're… you'll see RNAI, R-V-A-I?

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Daniel Barreto: R-O-A-I-V-R standing for remote. So, is it an inspection?

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Daniel Barreto: No, but the classifications look pretty much similar, except that they added the R.

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Daniel Barreto: Is the FDA 482, meaning the Notice of Inspection, issue? No, because there's no inspector going into your facility?

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Daniel Barreto: But it doesn't matter, the FDA continues to gather information from you.

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Daniel Barreto: Do you have timeframes to meet? Absolutely. And this is something that's very important, because if you're not able to meet the time frame, you should be able to communicate to the agency and let them know that you need whatever extra time. So keep that in mind.

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Daniel Barreto: Are you required to accept?

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Daniel Barreto: A regulatory, a remote regulatory system, or an RIE?

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Daniel Barreto: The answer is… Yes, for the mandatory.

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Daniel Barreto: No for the voluntary, however, listen.

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Daniel Barreto: When the FDA is telling you that it wants to engage in a communication with you.

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Daniel Barreto: As much as it's been said that something

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Daniel Barreto: is voluntary when you're dealing with the FDA.

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Daniel Barreto: If you asked me as a consultant, and I'm sure that if you asked any other consultant, I would say.

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Daniel Barreto: It's really not voluntary, because the agency has an interest in talking with you, number one. And number two, it is in your best interest.

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Daniel Barreto: To speak with the agency, to maintain a dialogue and communication with them.

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Daniel Barreto: Any… are documents requested by the agency? Of course they are going to be.

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Daniel Barreto: If the… is the FDA 483 issued, if required? There is no such a thing as an FDA 483 issued. However.

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Daniel Barreto: They will write a report that looks pretty much

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Daniel Barreto: Similar to a 483, and that document is also going to be a public document, the same that the regulatory assessment report, once it's completed, is going to

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Daniel Barreto: I mean, so, so, I'm not gonna take you through the whole thing here, but, is the agency obliged to make a conclusion?

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Daniel Barreto: No, but they will.

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Daniel Barreto: They will, because the SMG6001.1 provides for that type of activity. And my apologies for the answer that has no… the question has no answer. Can the agency, make a decision on the status of the product? That should be yes.

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Daniel Barreto: So my apologies. I left that out.

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Daniel Barreto: So, so, so, what I'm trying to say is… what's similar.

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Daniel Barreto: the outcomes are going to be more or less the same. Let's go to the next slide.

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Daniel Barreto: So, steps that, to effectively manage, a regulatory assessment. So, first is…

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Daniel Barreto: Listen, you need to become aware of the guidance documents.

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Daniel Barreto: So… so the FDA provides guidance for regulatory… remote regulatory assessment. There's a Q&A document, and that's the SMG6001.1.

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Daniel Barreto: And then, of course, there's Qpedia.

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Daniel Barreto: Because Kipedia is able to, in its database, to have all of these documents in place, and it's able to process any questions you may have with respect to, a remote regulatory assessment.

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Daniel Barreto: So, you need to… the second thing you need to do is to incorporate these key points of the guidance document into existing inspection readiness procedures.

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Daniel Barreto: or… you may be able to want to create your own RRA-specific procedure.

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Daniel Barreto: But you definitely need to make sure that you incorporate this type of guidance into your internal inspection procedures.

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Daniel Barreto: Then train your personnel on the RRA process. Let them understand and appreciate

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Daniel Barreto: What are the differences? What are the similarities? And in the end, what is the goal of an RRA?

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Daniel Barreto: The next thing is, as soon as you get the RA, it's just read it, understand exactly what they want, put a strategy around,

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Daniel Barreto: How is it that I'm going to respond to this regulatory assessment? What sort of documents? What are the best documents that I can put? Do I… do I…

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Daniel Barreto: actually put more documents that I… that the agency's asking for. If those documents, reinforce my position, of course you can do that.

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Daniel Barreto: But again, be smart about it.

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Daniel Barreto: Now, make sure your responses and supporting documents address the FDA expectation, right? So make it right the first time. You have one opportunity to let the FDA know exactly

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Daniel Barreto: that you're providing the right response. So don't think you're gonna get second, third chance from the FDA. The second chance you're gonna get, it's gonna be an inspection from them, and you don't want that, okay?

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Daniel Barreto: So, do not underestimate the potential consequences of the outcome of the process. So, you really try to understand that in the end, you want an outcome that is going to be positive for you.

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Daniel Barreto: Provide timely responses to the FDA, so don't sit on your butt. Get going, get working, put your inspector readiness team to work.

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Daniel Barreto: And whenever you have any doubts, seek the support from a consultant.

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Daniel Barreto: So, it may not be an inspection, but it serves the similar goals and objectives, so follow all your inspection management processes. Next slide, please.

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Daniel Barreto: So, here are some examples of RA outcomes that we pulled from the Kikipedia database. For instance,

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Daniel Barreto: This company, Thai Union, they got a warning letter regarding their tuna processing violations. You might say, well, I'm a drug person.

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Daniel Barreto: what does this have to do with me? No, what we are trying to show you is the consequences that could happen from a remote regulatory assessment.

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Daniel Barreto: So, but, Udo Medical in Mexico, they received a warning letter regarding leaks and mishandled complaints. So, so the FDA is looking at these things, and they're actually issuing, warning letters to companies. Next slide.

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Daniel Barreto: So, here are some, metrics that we were able to, to obtain. So, look at the, total number of,

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Daniel Barreto: RRAs, 683, so the FDA is taking this process seriously. And one thing that we all need to understand is, as the FDA gets more and more comfortable with these regulatory assessments.

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Daniel Barreto: The more they're gonna use them, the better they're gonna get at it.

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Daniel Barreto: So, so that means that also, we, the industry, have to get better at it. So,

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Daniel Barreto: This is… obviously, during COVID, there were more than now, but I expect that this… the regulatory assessments will increase. Next slide, please.

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Daniel Barreto: So, key findings,

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Daniel Barreto: of these trends, the highest, were in July 2022. 131 assessments in one month.

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Daniel Barreto: There is a decreasing trend, but it's because there's no COVID.

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Daniel Barreto: I do expect that, that they will increase, and so what we see, it's about 12 assessments per month. So,

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Daniel Barreto: I… I expect that, that things are gonna change, in terms of increasing RAs. Go ahead.

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Daniel Barreto: Not the same, more similar, and so here is an example of a number of warning, a warning letter that was issued to the company. So, it says, during a regulatory, remote regulatory assessment.

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Daniel Barreto: So it… the warning letter makes references, so… and… and they say here, we received your responses, right? And, in… in the company, the FDA is actually reviewing them, so…

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Daniel Barreto: Again, what I wanted to show with the… to you with this is.

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Daniel Barreto: wait a second, they're not inspection, but the outcome is the same. So, this warning letter, we suggest that you go to Keypedia to read it, if you get an opportunity.

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Daniel Barreto: Go ahead.

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Daniel Barreto: So what do we do?

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Daniel Barreto: If you, if you get an RRA warning letter, first, I have to say this, shame on you.

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Daniel Barreto: You had the best opportunity to actually get it right.

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Daniel Barreto: So if you… if you get a warning letter as a result… result of an RRA, you… you really screwed up. I'm sorry to say this, but you… you were totally in control of this process.

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Daniel Barreto: So, now that you've screwed up, seek support from an external company.

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Daniel Barreto: And now you need to prepare, for,

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Daniel Barreto: an inspection, because you definitely will get it.

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Daniel Barreto: Implement an inspection readiness letter plan.

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Daniel Barreto: Become ready for a follow-up inspection. It's going to happen.

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Daniel Barreto: And work hard during the inspection to achieve the highest level of performance and credibility. So.

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Daniel Barreto: RRA warning letters are green light for a follow-up inspection. It's unavoidable, so be ready for it. It's gonna happen sooner rather than later. Go ahead.

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Daniel Barreto: Conclusions or recommendations, so…

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Daniel Barreto: The, you know, the oversight and enforcement approaches used by the FDA may be different.

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Daniel Barreto: However, they pursue one objective, which is to determine whether or not, you know, you are in compliance.

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Daniel Barreto: So, proactive inspection and preparation… inspection preparation and readiness remains extremely important.

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Daniel Barreto: A positive record of performance and compliance.

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Daniel Barreto: definitely will keep the FDA away from your site, so…

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Daniel Barreto: The opposite is also true. So, look, look at these regulatory assessments as an opportunity.

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Daniel Barreto: Because this is… this is gonna be… this is gonna be of help. So, self-monitoring, self-regulation, has to become your cultural setting mantra.

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Daniel Barreto: And…

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Daniel Barreto: One thing that you can do, if you are not able to do anything else, embrace the right AI tools, for instance, Archipedia tool, to supplement your decision-making process. So that's… that's what I wanted to share with the audience. Any questions so far from…

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Daniel Barreto: Seth?

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Zephaniah Odidika: Thank you, Dan. This was really good. I'm just gonna dive into the GKI side. Okay, great. Perfect.

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Zephaniah Odidika: So, so Keypedia, so Keypedia is our platform's native AI, so essentially you can ask the Keypedia almost like a ChatGPT or a Claude, but instead it has

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Zephaniah Odidika: components of GKS is documentation. So, at GKS, we pull FDA guidances, annexes, IPCs, sorry,

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Zephaniah Odidika: Global regulatory guidances, as well as the guidance that

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Zephaniah Odidika: Dan was talking about, and you can put it into Keypedia, and then you can ask Keypedia to emulate an FDA investigator, or do anything with it. Find guide… find gaps in your analysis, or just find gaps in general.

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Zephaniah Odidika: If we ask Epedia to introduce itself.

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Zephaniah Odidika: This is what it says. I'm an FDA regulatory assistant. I can help you find information from the FDA databases, including 43s, warning letters, and inspections.

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Zephaniah Odidika: And so on.

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Zephaniah Odidika: I'm gonna piggyback off of what Dan said, and I'm gonna,

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Zephaniah Odidika: do a little deep dive on the, you know, medical device, warning letter, basically, out of Mexico.

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Zephaniah Odidika: So, this is what this warning letter would look like inside of the GKS platform.

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Zephaniah Odidika: Looks like they got it on January 8th, but there's more to that story than what's… what meets the eye. If you were to actually read the warning letter, as we will later, you will see some violation codes as well. The violation codes that are…

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Zephaniah Odidika: affected that the FDA deemed worthy.

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Zephaniah Odidika: This… this company had broken.

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Zephaniah Odidika: And essentially, that's what…

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Zephaniah Odidika: we can do at GKS. You know, whether it's routine inspection, a four-cause inspection, an RA, or any other interaction with the FDA, QPD can help you.

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Zephaniah Odidika: It can look out how every one letter is structured, from the issuing office, to the product type, to the related people.

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Zephaniah Odidika: You can also see if there's a PAI, a pre-approval inspection, or a for-cause inspection. You can also see if it's a RRA, RA recall investigation.

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Zephaniah Odidika: Nothing is too small for, the Keypedia platform.

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Zephaniah Odidika: going into the Unimedical, Born letter.

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Zephaniah Odidika: it seems like it was about 231 days, which is a very long time for a RRA, like Dan said, the FDA wants to see

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Zephaniah Odidika: what you're doing is good, and the fact that you didn't do well on an RA is, telling.

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Zephaniah Odidika: So, we can see if… if you were to read the warning letter, it's a very long warning letter, first and foremost, but the FDA requests documents for the first time on May 22nd.

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Zephaniah Odidika: And then, later on, the FDA.

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Zephaniah Odidika: on… on July 23rd, the RA was conducted.

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Zephaniah Odidika: Records were… records were reviewed. Again, no… there was no site visit.

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Zephaniah Odidika: And then from August to November 2025, the firm responded.

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Zephaniah Odidika: Let's just say the firm, not the firm, responded. And it's saying, like, oh, they're all inadequate.

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Zephaniah Odidika: And then on January 8th of 2026, earlier this year, The warning letter was issued.

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Zephaniah Odidika: Some key components of this warning letter, was there was one death that was found.

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Zephaniah Odidika: Which is not good.

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Zephaniah Odidika: I was… blood glucose dropped to 1.1.

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Zephaniah Odidika: The complaint was closed without an investigation.

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Zephaniah Odidika: And then also 11 months between the firm becoming aware of the problem and the FDA initiating a Class 1 recall.

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Zephaniah Odidika: There was about a 41,000

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Zephaniah Odidika: There was more than 41,000 complaints closed without an investigation between June 2023 and June 2025.

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Zephaniah Odidika: A lot of case numbers were closed without actually an investigation, which is not good.

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Zephaniah Odidika: And more than 5,000 leak complaints tied to the, to their, hypergelic… sorry, if I'm saying that right, and a DKA over about the same window.

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Daniel Barreto: Yeah, hyperglycemia.

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Zephaniah Odidika: There we go. Thank you, Dan.

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Zephaniah Odidika: It is telling, because every one of these data points was visible in public records before the F… before the warning letter was written.

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Zephaniah Odidika: Mod reports, Class 1 recalls, compliance trends.

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Zephaniah Odidika: The key thing about this is that QPEDA connects all these signals so that teams can see the pattern before the FDA does.

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Zephaniah Odidika: And that's where I'll leave it off for now. If anyone has any questions, please feel free to come off of mute and say your question out loud. We are also joined by the great Liggy Azubik, who also is able to answer questions, along with Dan and myself. So,

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Zephaniah Odidika: I'll pass it up… pass it over to y'all to ask any questions.

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Daniel Barreto: So, Ligia, I think you have a question.

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ligia zubik: Yes, yes. First of all, thank you, Dan and Zeph. Great presentation, good to know more, and how to answer and respond, and always good to have a procedure be prepared for RRA.

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ligia zubik: On the same note, I also want to compliment… I was looking on the website, I was also playing with the Wikipedia, so definitely very helpful to have this tool in our hands. I put one question in the chat, so…

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ligia zubik: Which regulatory framework are eligible for RRA?

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ligia zubik: And I have follow-up question, after. So, like.

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ligia zubik: any type of manufacturing facility, any type of operation, any type of CFRs to 10 to 11.

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Daniel Barreto: So it's, it's all applicable.

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Daniel Barreto: In other words,

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Daniel Barreto: What you… what's really different is that they don't call it an inspection, but the level of compliance that they are expecting is for you to comply against the existing regulations, so…

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Daniel Barreto: There's nothing's… Different from what they expect, so the objective remains the same, okay?

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ligia zubik: Yes, thank you, and the follow-up question, as I'm, like, working on something myself with some of the clients,

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ligia zubik: I'm assuming it would also apply to compounding pharmacists. So this would be, like, under section 503A and 503B?

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ligia zubik: I… pretty much believe it would also be applicable, and this type of facility can be subject to RRA.

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Daniel Barreto: I suppose that they could be. As far as I know, there are no exclusions to companies or operations that would be subject to RRA, so…

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Daniel Barreto: Why not? I don't see why not, yeah.

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ligia zubik: So now, like, from proactive approach, then, that's the easy question now. So let's say, now we know all this, what you just presented. How would you advise,

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ligia zubik: clients to prepare. Write an SOP, how to approach this type of inspection.

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Daniel Barreto: So, I always say, knowledge is power, right? So you really need to understand, in this dialogue, or in this type of interaction with the agency, you really have to understand

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Daniel Barreto: Where is it the agency's coming from, and what is the objective that they have, right?

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Daniel Barreto: So, and you also need to understand that you need to fulfill that objective in terms of providing to them

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Daniel Barreto: the information that they need to make a decision. Is the company compliant or not? Can we rely on that company or not?

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Daniel Barreto: So you have to make sure that you understand where the issues, the concerns, or the interest is from the agency, and you have to address

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Daniel Barreto: That request in a way that satisfies

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Daniel Barreto: The intent of the agency, which is to make a decision.

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Daniel Barreto: Yes, that company, we can approve this product. Yes, that… those corrective actions that they said that they were going to implement, they were implemented correctly.

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Daniel Barreto: Yes, we asked them about the container closure system, and they gave us sufficient information for us to be comfortable that the next time a patient uses

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Daniel Barreto: that medication, they will not have a sterility issue, etc, etc. Yeah. So it's a… it's exactly making sure that you understand. So knowledge is power.

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Daniel Barreto: But the only way you can gain knowledge is really by reading the guidance documents and then putting together the infrastructure that you have to put in place, so that the entire site is aware of the intent and the objective of a regulatory, remote regulatory assessment.

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ligia zubik: Yeah, yeah, thank you, Dan. I think, yeah, we're gonna learn from this webinar, and most of the facility have, inspection readiness, SOP inspection readiness program, but to take this to the next level and procedurize our array, that would… that's really great advice. Thank you, I'm glad we talked.

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Daniel Barreto: And again, you know, when I was contacted by my clients.

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Daniel Barreto: Yeah, and I looked at the responses that they put together.

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Daniel Barreto: I had to make sure that I was looking at their response from an FDA perspective. So this is important that the consultant that you

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Daniel Barreto: hire to help you, they have to sort of become devil's advocate. In other words, basically think the way FD inspectors would think, and then help you with making sure their response does exactly what it's supposed to do.

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ligia zubik: Very good, very good. I want to give other people opportunity, and I have one more question to Zeph.

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Daniel Barreto: Any other questions, Seth? If not, maybe we can… you can respond to Lydia's question, and then we can close.

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Zephaniah Odidika: Looks like no more questions in the chat, but if anyone has any questions, please feel free to come off mute.

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ligia zubik: Yeah, Zef, on the same note, thank you, very helpful, and to use Wikipedia.

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ligia zubik: The one advice from you, let's say now I have my new mission, I'm gonna prepare that inspection readiness, another SOP for RRA,

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ligia zubik: can I use, like, Wikipedia, like, to test, or do, like, mock, questions, or maybe that's questions to both of you. So, can I…

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ligia zubik: ask Wikipedia questions and build my documents based on the answers, or how that works?

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Zephaniah Odidika: Absolutely. You can, because

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Zephaniah Odidika: PPD is also pulling from guidances. It can act as an inspector, if you would like it to, or it can act as a… as you. So, you can also write a guidances based off of the, sorry, you can write, like, an SOP or your own internal.

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Zephaniah Odidika: documentation, based off the guidances that it has in the database. And from there, you're also able to make sure what is correct

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Zephaniah Odidika: You're also able to make sure that

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Zephaniah Odidika: What's correct in your document is based off of things that people have done wrong in the past, and also what is in the guidance.

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Daniel Barreto: Here's my challenge to the audience, because I don't want to answer this question, I want Wikipedia to answer the question.

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Daniel Barreto: And the question is this. You go to Kikipedia, and you ask Kikipedia to put together

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Daniel Barreto: a draft procedure on how I can manage regulatory assessments at my site. Let Qipedia help you to craft

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Daniel Barreto: that procedure, and see if Wikipedia puts together, you know, basically is worth you putting it into your own procedure. I've done it before, that's why I'm putting the challenge on the audience.

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Daniel Barreto: And Kipedia's pretty good at doing this.

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ligia zubik: Yes, very… yeah, yeah, good advice, always about, correct questions as well, or well-asked questions. Zef, can we have a link?

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ligia zubik: Wikipedia.

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Zephaniah Odidika: Yes, absolutely.

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Zephaniah Odidika: In the… in the follow-up email, there will be, this… this recording on, which will be a YouTube link. There's also going to be a custom

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Zephaniah Odidika: Report that, that you can also,

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Zephaniah Odidika: click. That all will essentially… we… I will be able to meet… to meet with you one-on-one, and then we can play with Keypedia, and then I can also give you a custom report based off of that.

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ligia zubik: Thank you.

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Zephaniah Odidika: Absolutely.

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ligia zubik: Cool, and definitely right timing for… My client, thank you.

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Zephaniah Odidika: Perfect. Thank you.

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Daniel Barreto: I just want to thank everybody for their attendance, Seth, before we go. And, I want to say a special hello to my friend, in, Sanofi, Germany.

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Daniel Barreto: Jens Sulzbacher. I hope all goes well with you, Jens.

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Zephaniah Odidika: Yes.

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Zephaniah Odidika: Thank y'all so much for joining.

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Zephaniah Odidika: like I said, there will be a email after this, and hopefully see you again next month.

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Daniel Barreto: Take care. Bye.

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ligia zubik: Fantastic, thank you all. Bye-bye.