Environmental Monitoring Considerations for Cell Therapy Products
A webinar course designed to help cellular therapy manufacturers in designing, implementing, and managing an environmental monitoring (EM) program that meets the criteria of being meaningful, manageable, and defendable. Several considerations are presented that are unique to cell therapy process manufacturing as opposed to more traditional pharmaceutical filling operations. These considerations will help manufacturers to tailor EM programs to their specific process providing greater value.
This 1.5 hour program is designed to help build technical knowledge in the concepts of EM principals, specifically for the cell therapy laboratory, Quality management, clean room manufacturing, and other support staff who are involved in cell processing operations in order to prevent adventitious contamination.
Why Should You Attend?
In this training you will be able learn what meaningful, manageable, and defendable EM programs look like in the cell therapy sector. Know the elements involved in an overall environmental monitoring program plan and answer the following questions:
- How do I calculate the number of sampling sites needed for my facility?
- What sampling frequency should I have?
- What are the best media and incubation conditions to use?
- What monitoring levels that should be met?
- What are the tools to adjust EM alert / action levels?
- When to identify microbial isolates and to what level?
- How often should short-term and long-term summary trend reports be generated?
- What elements should be considered and documented in excursion investigations?
These questions plus additional information will be presented that should help cell therapy manufacturers to have an environmental monitoring program that is appropriately tailored to cell therapy product manufacturing and managed in a way that meets regulatory expectations.
- Guidance documents
- ISO 14644-1
- EU Annex 1
- Setting up sampling plan for cell therapy labs
- Sampling types and volumes
- Sampling frequencies
- Media and incubation conditions
- Monitoring levels
- U.S. FDA
- EU / TGA
- USP <1116> contamination rates
- Managing the program
- Generating reports
- Adjusting EM levels
- Microbial identification
- Investigations and excursion response
Who will benefit?
Manufacturing / Laboratory 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.