Validation and Qualification Approach Outlined in New Annex 1 Revision
The updated revision of Annex 1 further emphasizes how product and process should be appropriately designed, qualified, validated, and, where applicable, subjected to ongoing verification to be used in GMP sterile manufacturing, thus focusing closely on validation and qualification topics.
It is mandatory that the manufacturers understand processes and control their variability. Guidelines suggest managing in accordance with Quality Risk Management (QRM) principles throughout the whole process, including the design stage, to better improve flexibility and higher predictability of outcomes.
In this free webinar you’ll learn:
- why validation and qualification are important in the pharmaceutical process
- how to to implement the best practices required by GMPs
Who should attend:
All professionals involved in GMP sterile manufacturing, especially:
- Quality assurance
- Quality control
- Production and project managers
Serena has a strong scientific background in Microbiology and Biotechnology. She worked in several pharmaceutical companies to support quality control departments. She is especially skilled in quality assurance procedures and has excellent knowledge of cGMP guidelines. She started her career as a quality technician, and over the years, she moved into management positions, working in immuno-chemical, chemical, and microbiological departments. She played a key role in many projects, such as: disinfectants strategy, environmental sampling plan definition, lean scheduling and release of products, product stability management, method and process validation, and change control. In PMS, she splits her time between Sterility Assurance and Risk Assessments for Environmental Monitoring.