2020 - Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Cleanroom Regulations, Classifications, Basic Background and Design Considerations
Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation
Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data)
Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures)
Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy)
Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program
Basics of Sterilization Processes- Physical and Chemical Processes
Bonus:Compliance Expectations, FDA Form 483’s and Case Studies