ANNEX 1 CHAPTER AND TOPICS | Module 4 | walid el-azab & stan o’neil

Course Program

Annex 1 Chapters and Paragraphs considered:

8. Production and specific technologies (I)

•  Terminally sterilized products (8.1 – 8.6)
•  Sterilization (8.34 – 8.49)
• Sterilization by heat and moist heat sterilization (8.50 – 8.65)
• Dry heat sterilization (8.66 – 8.70)
• Sterilization by radiation and with ethylene oxide (8.71 – 8.78)

Teachers

WALID EL-AZAB

Co-founder & Managing Director QP Pro Services
Extensive expertise in GMP of sterile products
BELGIUM

STAN O‘NEIL

Managing Director The Compliance Group Assistant Professor Trinity College Dublin
Honorary Associate Professor Royal College of Surgeons In Ireland
IRELAND

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