“Deconstructing Warning Letters” - Using Warning Letters to Illustrate the FDA and Health Canada CFRs

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Warning Letters are continuing to occur at a frequency that mirrors previous years. However, one of the major differences is that many of them are now originating in India, the second largest supplier of Active Pharmaceutical Ingredients (API) and finished drug products. The FDA, having recognized this, has now increased their staff to three offices and nineteen investigators within the country.

As a result of this enhanced presence, more Warning Letters are arising from this country and provide excellent examples of issues that everyone should heed. The Observations provide room for reflection upon not just these Observations, but also the CFRs that form their basics. Many of the Observations suggest that the Investigators are merely retrieving "low hanging fruit" and must ask the question of what will the Investigator find with the really difficult areas to include analytical chemical method validations, equipment qualifications, cleaning validations, bacterial endotoxin testing, etc.

The objective of this live and interactive webinar is to explore the various CFRs and observe how these various regulatory requirements lead to Observations and determine what the Observations mean, how the regulators interpret the requirements and how they are reflected within the final document that the Client receives. This live webinar is a MUST for anyone in your organization that is required to reply to or review regulatory Observations.

Learning Benefits:
-Explore the most common Observations that the Agency has issued
-Understand the requirements and actions that an Organization must take based on these common Observations
-Review the issues that occur when an Organization does not fully understand the Observations
-Review Case Studies of specific Warning Letters
-How to share Warning Letters that are immediately relevant and actionable
-Review the “deconstruction” of a Warning Letter
-Review current FDA inspectional emphases in Warning Letters
- How to use Warning Letters to anticipate inspectional priorities

Webinar outline and time breakdown:

12:45 PM Log In Period
01:00 PM Introduction
01:10 PM Definitions,
Understanding the Warning Letter process – from Inspection to Enforcement Exploration of Regulatory Requirements,
Peruse the Derivation of the Regulatory Requirements,
How to analyze a Warning Letter – Code phrases, prioritization points and more
How to analyze a Warning Letter – Code phrases, prioritization points and more
How to read “between the lines” of a Warning Letter,
Identification of the routine sampling requirements,
02:00 PM Break
02:10 PM How to share Warning Letters that are immediately relevant and actionable,
Review current FDA inspectional emphases in Warning Letters,
How to use Warning Letters to anticipate inspectional priorities
Review of current Warning Letters
03:00 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
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Incoming Materials and Receiving

Schedule & Deliver this Live Training Webinar Privately to Your Group


Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>




Course Number: 226

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