Basic Principles of Microbiology for Cell Therapy Manufacturing
An introductory webinar course designed primarily to educate aseptic cell therapy process operators in the basic principles of Microbiology as required for regulatory compliance and best industry practice. Concerning staff training, the 2004 FDA guidance: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, states the following: “Fundamental training topics should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety…
This 90 minute program is designed to help build technical knowledge in the concepts of Basic Microbiology, specifically for clean room cell therapy laboratory and other support staff who are involved in manipulation of cell therapy products in order to prevent adventitious contamination.
- Regulatory Requirements and Guidelines
- Understand Basic Bacteriology
- Environments and habitats
- Classification and taxonomy
- Gram-positives, morphology and sources
- Gram-negatives, morphology and sources
- Fungi, morphologies and sources, mold concerns
- Understand Common Environment, Clean Room, and Human Contaminants
- Applications for Cell Therapy Manufacturing
- The Gram stain as product release test
- Common contaminants from cell collections
- Clean room behavior (Do’s and Don’ts)
Who will benefit?
Mfg & Lab Staff, Quality Control, Quality Assurance, Facilities, Validation, Regulatory, Clinical Investigators
Timothy D. Wood has over 25 years experience in Quality Control Microbiology in cGMP industry. Tim is founder and Principle Consultant at Cell Therapy Microbiology Consulting designed to assist the cell therapy industry in developing and improving microbiology methods and contamination controls. For over 13 years Tim was at Dendreon helping to get the autologous cellular therapy product PROVENGE through pivotal trials, FDA approval, and expanded to multiple cGMP facilities. Tim was responsible for the development of microbiological policies, environmental monitoring programs, and microbiology and aseptic training programs. Tim has worked as a Microbiologist at several companies including ICOS, Xcyte Therapies, CellPro, and Abbott Laboratories. Tim received his Bachelors degree in Biology from Pacific Lutheran University, Tacoma, WA.