Tuesday, 6 March 2018

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

Forthcoming webinar on sterile products manufacture / EU GMP draft Annex 1.

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. This is discussed in a forthcoming webinar.

Instructor: Tim Sandle
Product ID: 507684

Date: Thursday, 15 March 2018
Time: 10:00 AM PDT, 01:00 PM EDT 
Duration: 60 Minutes

  1. What the new Annex 1 contains and what it excludes
  2. What are the differences between the new requirements and previous requirements
  3. The relationship between the Annex and ISO 14644
  4. Understanding microbiological risks
  5. Understanding what is required for a contamination control strategy
  6. 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 Benefitws
  • Production managers
  • QA
  • QC
  • Microbiology
  • Regulatory personnel
  • Business intelligence
For details see Online Compliance Panel.

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