Why Should You Attend:
As we know all too well, the pharmaceutical industry an it’s allied industries are among the most heavily regulated businesses in the United States. One of the things that we can depend on is that from time to time, an FDA investigator will arrive unannounced to perform an inspection to see if we are following all of the applicable GMP regulations. The inspection may take a few hours or it may take far longer. No matter what, we must always be prepared for an inspection. This presentation will provide practical advice regarding how to prepare for these inspections so that your facility will pass with flying colors.
Areas Covered in the seminar:
Critical areas of inspection and how to prepare for them:
Who Will Benefit:
This program is designed to provide an overview of the GMP regulation and how FDA inspects a facility to assure compliance with them. Knowing this, suggestions are made to prevent FD 483 citations.
This program will be of value to all personnel responsible for the following functions:
James R. Harris,, PhD is a veteran of the pharmaceutical Industry and the president of James Harris Associates, an international consulting firm that specializes in the regulatory aspects of pharmaceutical, Biopharmaceutical, and device manufacturing. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types. He authored the original validation guideline for computerized systems used in drug manufacturing and has recently written a chapter on GMPs for the Pharmaceutical Manufacturing Handbook which will be published soon by John Wiley & Sons.
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