At the 2022 ISPE Aseptic Conference I spoke on “Contamination Control, Risk and the Quality Management System“.
Contamination Control is a fairly wide term used to mean “getting microbiologists out of the lab” and involved in risk management and the quality management system. This presentation will evaluate best practices in building a contamination control strategy and ensuring its use throughout the quality system. Leveraging a House of Quality approach, participants will learn how to: Create targeted/ risk based measures of contamination avoidance; Implement Key performance indicators to assess status of contamination control; and ensure a defined strategy for deviation management (investigations), CAPA and change management.”
Handouts:
- Example table of contents for a Contamination Control Strategy
- Regulatory Requirements for Contamination Control
Posts with the tag “Contamiantion Control“