ANNEX 1 CHAPTER AND TOPICS | Module 2 | tracy moore

Course Program

Annex 1 Chapters and Paragraphs considered:

4. Premises

• General guidance for premises design and qualification:
• Barrier Technology Isolators and RABS (4.1 – 4.22)
• Cleanroom and clean air equipment qualification (4.23 – 4.32)
• Disinfection of cleanrooms (4.33 – 4.36)

Teacher

TRACY MOORE

Fonder and CEO at TM Pharma Group Ltd and former MHRA Expert EU GMDP Inspector
UK

Why choose our course?

This course will allow you to achieve the following learning outcomes:

• To understand thoroughly the requirements of Annex 1
• To be guided in the interpretation of critical requirements
• To learn how to implement the requirements in terms of equipment, procedures, and training, with examples

Who's It for?

Industrial pharmacists and other professionals working in the pharmaceutical sector who are interested in the manufacture of sterile medicinal products