ANNEX 1 CHAPTER AND TOPICS | Module 8 | patrizia muscas & francesco boschi

Course Program

Annex 1 Chapters and Paragraphs considered:

9. Environmental and process monitoring PART 2

Aseptic process simulation (9.32 – 9.49)

10. Quality Control

Guidance on some of the specific Quality Control requirements relating to sterile products (10.1 – 10.11)

Teachers

PATRIZIA MUSCAS

Sterility Assurance Director, Global TS.MS Eli Lilly and Company
ITALY

FRANCESCO BOSCHI

Sr. Manager Technical Services – Global Microbiology and Aseptic Support Team (MAS) Pfizer
ITALY

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