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Half-Day Seminar

This seminar covers the fundamentals of GMPs in the USA per Code of Federal Regulations (CFR). Participants will learn how GMPs and the Food and Drug Administration (FDA) emerged in the USA and how they have evolved.  We will discuss the details required by the GMPs from buildings, personnel, components, manufacture, testing and release of product to documentation practices and more.  Examples of real 483s and Warning Letters will demonstrate why regulations are to be followed.

Topics Include:

  • GMPs General Concepts (definitions, history, laws)
  • Overview of Code of Federal Regulations
- Role of Quality Control
- Personnel
- Buildings and Equipment
- Components, Containers and Closures
- Production Controls
      - Packaging and Labeling
- Laboratory Controls
- Documentation
  • Enforcement of Regulations
- 483s, Warning Letters, Consent Decrees or Worse
  • What makes GMPs current? How do you keep up?
  • Importance of GMPs
  • Your responsibility in a GMP environment
    Fundamentals of Good Manufacturing Practices  (GMP's)
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(919) 801-4830 | info@EliteMicroSource.com