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Packaging Validation 101, Part 2 (Process Validation)

June 3, 2021

11:00 am MDT

Jennifer Gygi and Wendy Mach

ISO 11607 is divided into two parts. Part 1 covers making and validating sterile barrier packaging which will be covered in a separate webinar. ISO 11607 Part 2 covers packaging process validation. We will be discussing:

  • Basic validation concepts
  • Defining the process
  • Seal acceptance criteria
  • Sealer qualifications
  • Routine process monitoring