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Methods for Detecting Mycoplasma Contamination In The Manufacture Of Pharmaceuticals And Biologics

Thursday, 10 January 2019 10:00 AM PST, 01:00 PM EST 

Training Duration = 60 Minutes                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

Understanding which compendial and non-compendial methods to use for Mycoplasma detection is a must for companies in order to meet the requirements outlined by regulatory bodies (EU and FDA).

This webinar will discuss the various methods of detection and the strategy needed to ensure the cell line and cell line product meet the safety requirements of the product.

Learning Objectives:

  • Regulations
  • Understanding why Mycoplasma is important to product quality
  • Compendial Methods
  • Non-compendial methods
  • Advantages of each method
  • Disadvantages of each method
  • Where in the process you can use the methods discussed

Why Should You Attend:

Mycoplasma testing is a required testing method for determining the quality of your cell line and the cell line product. Throughout the production of the cell line, mycoplasma testing is required by the regulatory bodies (EU an FDA). Methods for determining Mycoplasma must meet the requirements of USP <63> and EP 2.6.7.

As outlined in this program are compendial methods for detecting Mycolplasma and non-compendial methods for detection. The objective of this webinar is to discuss the methods of detection and the advantages and disadvantages of each. As well as discuss the importance of having a Mycoplasma free cell production process.

Areas Covered

  • FDA regulations
  • EU regulations
  • USP <63>
  • Non-compendial based methods for Mycoplasma detection
  • Compendial methods for Mycoplasma detection

Instructor Profile

Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas.

Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU.

Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.