ANNEX 1 CHAPTER AND TOPICS | Module 1 | walid el-azab & marta rodriguez

Course Program

Annex 1 Chapters and Paragraphs considered:

2. Principle

General principles as applied to the manufacture of sterile products – CCS (2.1 – 2.7)

3. Pharmaceutical Quality System (PQS)

Highlights the specific requirements of the PQS when applied to sterile products (3.1 – 3.2)

7. Personnel

Guidance on the requirements for specific training, knowledge and skills. Also gives guidance regarding the qualification of personnel. (7.1 – 7.18)

Teachers

WALID EL-AZAB

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

BELGIUM

MARTA RODRIGUEZ
Quality Assurance
Quality Control & Manufacturing Expert in AEFI

SPAIN

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