Course Description:

Warning Letters continue 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 across the country.

As a result of this enhanced presence, more Warning Letters are arising from India and they provide excellent examples of issues that everyone should heed. The observations provide room for reflection and a better understanding of CFRs (210/211) that form their basis. Many of the observations suggest that the investigators are merely retrieving low hanging fruit and one must ask the question what will they find within difficult areas like analytical chemical method validations, equipment qualifications, cleaning validations, bacterial endotoxin testing, etc.

This two day seminar will instruct attendees on:

  • How to deconstruct Warning Letters to determine what is boilerplate and what is meaningful.
  • The contents of most Warning Letters and their essence.
  • Warning Letter citations and best practices to avoid them within your facilities.

Using a variety of Warning Letters categorized to represent major observations as well as other highlighted FDA observational findings from both Form FDA 483s and Warning Letters, attendees will be able to establish a foundation to examine their own facility and learn whether any of the most frequently cited observations might relate to their firm and its Good Manufacturing Practices.

The objective of this interactive two day seminar is to:

  • Explore the various CFRs (21 CFR 210/211)
  • Discern how these various regulatory requirements lead to observations
  • Determine what the observations mean
  • Understand how the regulators interpret the requirements
  • Understand how they are reflected within the final documents the client receives – be it a Form FDA 483 or a Warning Letter

This seminar is a must for those who reply to or review regulatory observations.

Learning Objectives:

  • Review the elements within a Warning Letter that constitute the boilerplate
  • Understand those areas that establish the essence of a Warning Letter
  • Explore the most common observations within Form FDA 483s and Warning Letters based on FDA’s own summaries
  • Review the various words and key phrases that may alert a company as to the agency’s thinking
  • Obtain an interpretation of the citations within both selected and groupings of Warning Letters
  • Understand the requirements and actions that a company must initiate based on these common observations
  • Review various categories of Warning Letters and how they relate to 21 CFR 210/211
  • Review various case studies

Who Will Benefit:

Staff involved in the non-sterile/aseptic processing of pharmaceuticals to include parenterals will benefit from this seminar. To name a few:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project facilitators/managers
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality control
  • Microbiology practitioners
  • Document control specialists

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  1. Overview of the Elements of a Warning Letter – The Boilerplate vs. the Essence
  2. Exploration of the Most Common Observations within Form FDA 483s and Warning Letters Based on FDA’s summaries
  3. A Review of the Last Four Years and the Variation in Citations
  4. A Review of the Various Words and Key Phrases that May Alert a Company as to the Agency’s Thinking

  1. Breaking Down the Warning Letters by Type and Common Groupings
  2. The Requirements and Actions a Company Must Initiate Based on Common Observations
  3. The Impact of Observations on the Various CDER Full Inspection System Options
  4. GMP Inspections – What to Expect
  5. Case Studies and Recent Warning Letters

Meet Your Instructor

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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