Walid El Azab, Technical Services Manager for STERIS Life Sciences, will be presenting the analysis and assessment of the impact of the changes that are laid down in the draft Annex 1 regarding the contamination control program. The rational for Annex 1 "Manufacture of Sterile Medicinal Products" revision is to tide up with current sterile manufacturing processes, reinforce the need for the manufacturer to keep up with current and innovative technologies. There is a clear emphasis on minimizing the risk of microbial, particulate and pyrogen contamination for sterile processes. Manufacturers must control processes, equipment, and facility by adopting Quality Risk Management (QRM) and ICH Q9 principle. The goal of a QRM is to demonstrate that critical process, equipment, utilities, and personnel, including critical programs such as cross-contamination and sterility assurance, are adequately controlled to ensure product compliance with specification and patient safety.
This event is free to ISPE members through the generosity of our sponsor.
This webinar will be held through an UberConference. Log in information will be provided to those registrants 24 hours in advance of the webinar.