Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
: 3 Feb 2021 - 4 Feb 2021
Type: Conference - Virtual, Training, Seminar
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, data trending, microbiological processes/methodology and cleanroom cleaning/disinfection.
The types of micro-organisms and 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.
Who will benefit:
This training will benefit those involved in the manufacturing, processing, testing, and release of sterile and non-sterile products. It will provide the attendee an understanding of the basic concept of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation and use of cleanrooms as well as the typical sterilization processes (physical and chemical) within various industries such as the pharmaceutical, biotechnology, drug, biologics, medical device, and In-vitro diagnostics product manufacturing industries.
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