Onsite Training

Onsite Training Opportunities

Cell Therapy Microbiology Consulting provides onsite cGMP / cGTP training programs customized for cellular therapy operations and related HCT/Ps.  Learn in an informal face-to-face atmosphere where CT Techs, Manufacturing Operators, Quality and others can learn and gain further knowledge in microbiology, contamination controls, and related topics. 

Advantages

  • Convenience
  • Training for Lab and Operations staff at time of your choosing (day or evening shift)
  • No disruption in operations or product testing schedule
  • Train entire staff at your convenience
  • Material customized for unique nature and nuances of cellular therapy operation

Training Topics Include:

  • Environmental Monitoring (EM)
  • Rapid sterility options
  • Performing and interpretation of the Gram Stain with CT products
  • Aseptic processing
  • How to work in and introduce items into the BSC
  • Cleaning and sanitization

 Environmental Monitoring (EM)

  1. A 2-hour introductory overview of EM for cellular therapies.  Includes available sampling methods and equipment for all phases from early clinical development such as Phase 1-2, or those advancing to Phase 3 or beyond toward licensure and commercial.  Great for those new to EM programs in GMP / GTP setting or new to cell therapy applications.
  2. Session on designing, implementing, managing an appropriate risk-based EM program.  A great way to start making EM program more efficient and meaningful.

Rapid Sterility

  1. A 2-hour session to provide guidance on validating or bringing in-house rapid or alternate sterility testing for cell therapy products, whether in-process or final product or both.  Validation strategies compliant with FDA biologics 21 CFR 610.12 are given.  Further training ensures that tests are performed appropriately to protect against contamination, are adequately investigated should positives occur, and are maintained in a validated state whether in-house or transferred to other site.  Excellent for those considering bringing sterility testing in-house from contract lab, or those desiring to reduce turnaround time.

Onsite Training Form