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Understanding and Applying USP 797 Updates
WEBINAR

In an effort to prevent harm through contamination, the U.S. Pharmacopeial Convention has been working on a series of proposed changes to USP Chapter 797, Pharmaceutical Compounding– Sterile Preparations. USP <797> published revision June 1, 2019 this becomes effective Dec 1, 2019

Watch this webinar to learn:

  1. Purpose of the changes
  2. Changes to classification and impact to Beyond-Use date
  3. Emphasis on terminal sterilization preference
  4. Personnel qualification requirements and frequency, quantitative/qualitative measures
  5. Requirements for Certification of Classified Clean Rooms
  6. Monitoring of environmental quality and control
  • Speaker

    Lisa Lawson

    Global Pharma GMP Advisor, Particle Measuring Systems

    Lisa G. Lawson has over 25 years’ experience in supporting large and small pharmaceutical companies in contamination control, including cleaning and disinfection strategies, aseptic manufacturing and use of risk-based approaches to microbiological quality challenges. She spent 16 years working for Amgen in microbial and mammalian cell culture manufacturing support and helped gain commercial FDA and international regulatory approval of the EPO/NESP manufacturing facility in Longmont, CO.