Duration: 90 Minutes


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FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. FDA requirements for qualification and validation will be discussed.

Lack of adequate qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and manufacturing and cleaning process validation will benefit from a review of the relevant FDA rules, written and unwritten. Those involved in hosting FDA inspections will also benefit.


Areas Covered in the Session :

  • General FDA GMP information requalification and validation
  • Equipment Qualification
    1. IQ
    2. OQ
    3. PQ
  • Computer System Qualification and Part 11
  • Manufacturing and Cleaning Process Validation
    1. Specifications
    2. When to test
    3. What to test
    4. How much to test

Who Should Attend:

  • Personnel responsible for equipment qualification
  • Personnel responsible for computer system qualification
  • Personnel responsible for manufacturing process validation
  • Personnel responsible for cleaning validation
  • Regulatory Affairs, Regulatory Compliance
  • Quality Professionals

Course Director: DR. LOREN GELBER

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.