Key GMP Systems in Pharmaceutical and Biotech Labs 2015

  • 12-13 Feb 2015
  • Philadelphia, PA, United States

Description

Key GMP Systems in Pharmaceutical and Biotech Labs 2015 is a seminar that covers topics such as:

  • FDA requirements for the equipment program
    • Equipment operation and maintenance
    • Equipment Qualification
  • FDA requirements for OOS Investigations
    • CAPAs, Investigation Conclusion and Documentation of the Investigation
    • What are the Phases of an Investigation
    • Common pitfalls; 483s related to OOS investigations and lessons learned from them
  • FDA requirements for method validation
    • Requirements for different method types
    • Overview of relevant ICH guidances and USP [1226]
    • S related to method validation and lessons learned
  • FDA requirements for Pharmaceutical and Biologics Stability Programs
    • Stability study requirements for Phase I, Phase II and Phase III clinical studies
    • Overview of ICH and WHO requirements for Stability Programs
    • S related to Stability Programs and lessons learned
    • Stability methods and specifications

Key GMP Systems in Pharmaceutical and Biotech Labs 2015 brings together R&D chemists, supervisors and managers, QC chemists, supervisors and managers, Regulatory Affairs personnel, QA Managers and personnel.

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Important

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Event Categories

Health & Medicine: Medical laboratories, Pharma
Science: Laboratories, Life Sciences & Biology
Technology: Biotechnology

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