Contamination Control Program for Cell Therapy Products

Description:

A webinar designed to provide an overview of the key elements necessary for a sound contamination control program for manufacturers of cell therapy products and other HCT/Ps for human use.

This 90 minute program is designed to help build technical and practical knowledge for the manufacturers of cell therapy products and HCT/Ps.

 Why Should You Attend?

In this training you will be able understand many of the terminologies used in industry and how they apply to contamination control. Understand the Do’s and Don’ts for working in clean rooms and laminar flow Biological Safety Cabinets. Be able to answer the following questions:

1. How many particles does the average person shed?
2. What are the pre-requisites prior to performing aseptic gowning?
3. Who should not be permitted into the clean room processing area?
4. What gown sampling locations should be considered for cell therapy operators?
5. What area classifications are required for cell processing and where is that stipulated?
6. How many times and how often to perform operator media fills and aseptic process validations (APVs)?
7. What items to consider for qualification of components and ancillary materials?
8. What is the best way to transfer materials into cell processing area?
9. How should disinfectant efficacy studies be conducted?
10. What is meant by disinfectant rotation?

The information presented should help cell therapy manufacturers to gain a better understanding of best industry practices of an overall contamination control program.

Topics:

• Guidance and Regulatory Requirements
• Definitions
  • Sterile
  • Aseptic
  • Sterility assurance level (SAL)
  • Aseptic processing
  • Aseptic vs. sterile
• Key Elements
  • Trained and Qualified Personnel
    • aseptic gowning & technique
    • clean room behavior
    • working in laminar flow cabinets
    • cell processor qualification & media fills
  • Buildings and facilities
    • materials and surface
    • area classifications
    • environmental controls and monitoring
  • Components, Raw and Ancillary Materials
    • reagent and AM qualification
    • component sterilization
    • materials transfer
  • Sanitization and Disinfection
    • modes of action
    • microbial resistances
    • application and contact time
    • efficacy studies

Who will benefit?

Laboratory Staff, Manufacturing, Quality Control, Quality Assurance, Validation, Facilities, Regulatory

Instructor Profile:

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.