Reducing your Exposure to a GMP FDA Warning Letter

Duration: 75 Minutes
Attending this webinar will help participants understand how even simple things can affect FDA actions in the future. You will learn what actions and steps are important during and after an inspection. Understanding what you should and should not do with FDA plays a major role in preventing regulatory action that could have been avoidable. This webinar will also examine how to proceed if you do receive 483 observations and what actions on your part can reduce the probability of getting a Warning Letter from the FDA.
Instructor: Max Lazar
Product ID: 501123
Objectives of the Presentation
  • Learn what should you do after the inspection is over?
  • What should be fixed immediately and why?
  • Time commitments to consider in your interactions with FDA
  • Understanding retrospective reviews that may be appropriate
  • What prospective actions should be considered?
  • Procedural revisions that may be considered and implemented
  • Learn why: Speed is always a consideration
Why Should you Attend
An FDA Form 483 observation is an opinion presented by an FDA investigator in the course of an inspection and does not always need to be a serious matter. However, if it results in the FDA issuing a Warning Letter - that is a completely different situation. A warning Letter is one thing that you would want to avoid if at all possible. Warning letters carry with it a judgment of non-compliance for your firm and it is something that should not be ignored. How you handle your interaction with FDA through the initial inspection will impact how and what FDA will expect or demand from your organization.

Areas Covered
  • How to prepare for inspections
  • What should always exist during an inspection?
  • What systems will get the greatest attention from a regulatory agency?
  • How can you reduce your risk for a Warning Letter?
  • How does past regulatory history impact your future?
  • What do you do after receiving a 483 observation?
  • How do you determine if a serious risk exists?
Who can Benefit
  • Quality Control
  • Quality Assurance
  • Production
  • Laboratory
  • Warehousing
  • Distribution and even Development personnel that are Supervisory
  • Management or directly performing regulatory related activities or support.
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance.

His almost 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s (PMA) Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings during his career including SOCMA, PDA, DIA, the original IVT, and PhRMA.

Max was named by PhRMA, Topic Leader and voting member of the ICH Q7A team that negotiated and developed the ICH API GMP document.

For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”

He represented USA industry at significant API meetings including the BPC PIC/S Conference in Canberra, Australia and the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. Max was named as PhRMA’s representative on the FDA PQRI initiative for the initial Bulk Substance projects. He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005), re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee, and is currently an official member of the USP water panels (2010-2015).
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