FDA GMP Inspections; Preparation, Successful Strategies and Logistics

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>

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Over the last several months, reputable companies that had been looked to as leaders in the field have been inspected by agencies (FDA, EMA, HPB) and have been brought to their knees after performing poorly in these inspections. What has gone wrong? Are they truly operating that badly? Or have the expectations of the agencies changed? Just how well do you believe you would perform? Now is not the time to gamble with your hard earned reputations. The key to success is to think like an FDA or EMA inspector. How can you do that? Simply learn from somebody with the inside know. Europeans and FDA have published articles and guidances to aid their inspectors. You can use these tools to help yourself.

The key elements to prepare for the inspection and get off on the right foot include, knowing when they are likely to come knocking, knowing what they will focus on, having your systems operating and documents ready and above all having a team ready that anticipates the inspectors’ every move. To do that you must clearly take control and demonstrate to the agency inspectors you know what you are doing.

This live training webinar will walk you through the elements you should plan for, including the timing and the logistics of preparation for the inspection. We will walk you through, step by step, the interactions with the inspectors during the introductions, the actual inspection including how to deal with the tough questions. We will describe successful inspection strategies and logistics that have brought excellent outcomes and been complemented by inspectors. Even the best prepared teams can and do get observations that must be addressed. We will describe the pitfalls in responding to these observations and how to put together a solid systemic response, whose commitments and rugged CAPA can be tracked to completion and their effectiveness checked. We will describe many examples of where companies have not responded or addressed issues satisfactorily, resulting in significant warning letters and worse and most importantly how to avoid it yourself.

Learning Benefits:
-Plan prior to the inspection and be ready when the agency walks through the door.
-Predict the likely timing so as to be able to begin your preparations early.
-Predict the likely areas to focus on – the agency hot buttons.
-Know how to conduct a GAP analysis with the mentality of an FDA inspector that will help you to identify your weak points and develop a response strategy to agency queries.
-Develop an efficient and effective CAPA system to close the gaps and eventually track your commitments.
-Train the best people for the inspection and keep the loose cannons at bay.
-Craft a strong set of responses to the observations for submission to the agency and track them to completion.

Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:

Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
Health Canada regulations for pharmaceutical and biotechnology products including appropriate annexes such as 1, 2, 3, 18.
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU, including Annex 13.
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH.

Webinar outline and time breakdown:

Time*
12:45 PM Log In Period
1:00 PM Introduction
1:10 PM The what, when and how of preparation,
Timing of the surprise inspection,
What will be covered in the inspection,
Hot topics for the inspection,
2:00 PM Break
2:10 PM Tools to help you prepare,
Things to look at in detail,
Logistics preparation,
Conduct in the inspection,
Keeping control of the inspection,
Responding to the agency,
Conclusions,
3:00 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena
Schedule & Deliver this Live Training Webinar Privately to Your Group
 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

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"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

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"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland


Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>