EU GMP Annex 1 - What's New for Sterile Product Manufacturing?

Duration: 60 Minutes
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A major revision is taking place with the European regulations covering the manufacture and distribution of sterile products. This is the first major update in 20 years, with the new draft text bringing in many changes, several of which will be far reaching.
EU GMP Annex 1
Instructor: Tim Sandle
Product ID: 507684
Objectives of the Presentation
  • What the new Annex 1 contains and what it excludes
  • What are the differences between the new requirements and previous requirements
  • The relationship between the Annex and ISO 14644
  • Understanding microbiological risks
  • Understanding what is required for a contamination control strategy
  • New emphasis on quality risk management
Why Should you Attend
To learn about the considerable number of changes made to sterile products manufacturing changes that are forthcoming. Although the Annex is applicable to Europe, it was written in conjunction with U.S. FDA and it signals the latest developments with global regulatory thinking.

Areas Covered
  • Sterile products manufacture
  • Aseptic processing
  • Sterilization
  • Environmental monitoring
  • Microbiology
  • Contamination control
  • ISO 14644
  • Cleanroom classification
  • Corrective and preventive actions for contamination incidents
  • Quality risk management
Who will Benefit
  • Production managers
  • QA
  • QC
  • Microbiology
  • Regulatory personnel
  • Business intelligence
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Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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