CMC Analytical, Comparability and Stability Studies for Biotechnology Products

March 15, 2012 7:50 AM

Pharmaceutical Training International is organizing the CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products training in New Jersey, USA on 26-27 June 2012.

If you attend the 2-days training course, you will be able to:

  • Clarify the latest CMC regulatory requirements for biotech products to ensure successful marketing applications
  • Assess comparability and stability considerations for biotech product specification
  • Design and develop your biotech stability protocols by identifying the key practical details to address
  • Validate your stability testing methods appropriate for each phase of development
  • Identify which characteristics of a biotech product require analytical assessment
  • Follow the ICH, FDA and USP guidelines for analytical method validation
  • Identify and implement key considerations for biotechnology laboratory testing

If you are interested, the website of the training is:

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  • Please advise cost of this program. – CMC Comparability

  • Biosimilar News

    We only share the event information on our pages; you can find the webpage of the event at the end of the post..
    fyi please,

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