Annex 1 draft, Contamination Control Strategy, an Implementation Approach
26 Jun 2020 | 5-6.30pm | Online Session
Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality (EU Annex 15, ICH Q10, Q11). The draft Annex 1 introduces a "Contamination Control Strategy" (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulates contamination.
During This webinar, an implementation layout to implement the CCS will be discussed:
- Part I: Implementation approaches to formulate and deploy a successful CCS
- Part II: Processes and environments that must be scanned to formulate a CCS
- Part III: Methods to make the strategy work as intended by implementing the correct control strategies
- Part IV: Ways to evaluate the effectiveness of a CCS formulation and implementation.
Conducted by:
Walid El Azab,
Senior Manager, Technical Services, STERIS Life Sciences, Belgium
An Industrial pharmacist, a Qualified Person and Lean Six Sigma green belt, Walid provides technical support related to cleaning, disinfectants, sterility assurance and process validation.
Walid is an active member of the PDA, ISPE, ECA, and A3P with numerous published articles and book chapters on contamination control. He is also active with the A3P GIC working group on sterilization, and he leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and he is also part of the ECA task force regarding the revision of the EU GMP Annex 1. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th) and biomanufacturing. He is also an Editorial Committee Member of the PDA Letter. Finally, Walid is a board member of the ISPE Belgium affiliate and Secretary of the Belgium Qualified Person (UPIP-VAPI) association.