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:
Who should Attend :
CEO of Microrite
Technology & Market Development Manager at Charles River Microbial Solutions
Managing Director of Charles River Laboratories (Singapore)
Director of Technology and Market Development at Charles River Laboratories
Contamination Control Expert at Microrite