The 2021 PDA Cleanroom Qualification: Current Regulatory Expectations workshop is an extension to the 2021 PDA Pharmaceutical Manufacturing & Quality Virtual Conference.
Cleanroom Qualification - Current Regulatory Expectations
Often companies face excessive environmental monitoring excursions in cleanrooms as well as media fill and product failures despite the facility being qualified. Gaps in qualification can lead to severe consequences, delays in production and even regulatory scrutiny.
A successful qualification depends upon multiple milestones; each addressed with a thorough knowledge base and process control. Understanding the relevance of each step during design and qualification of cleanrooms provides confidence in the contamination control effect of the cleanrooms and barrier systems.
Areas Covered in the Session
- Concept of cleanroom qualification
- Regulatory requirements related to cleanroom qualification
- Key qualification steps
- Why qualified cleanrooms fail
- Case studies related to cleanroom issues detected post qualification
- Discussion on regulatory observations which are a result of poorly qualified cleanrooms
- Importance of microbiological testing during performance qualification
- Real world examples – impact of accurate microbial identifications on clean room validation and future operations
Trainers / Speakers
- Ziva Abraham, Microrite
- Morgan Pollen, Microrite
- Ulrich Herber, Charles River Laboratories
- Duncan Barlow, Charles River Laboratories