ISO 14644

2 Day Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers Course - September 8-9, 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 14, 2021
Health, General Health, Articles, Academic disciplines, Hygiene, Laboratory techniques, Filters, Rooms, Cleanroom, Semiconductor device fabrication, Telecommunications engineering, Contamination control, Sterilization, ISO 14644

The "Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers" training has been added to ResearchAndMarkets.com's offering.
  • This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.
  • The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed.
  • The various regulatory bodies' requirements such as 21 CFR Part 211 (mostly relevant 211.113 "Control of microbiological contamination", ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice") amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.