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      Implementing a Compliant Stability Program for Biologics in Fremont

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      June 5, 2019

      Wednesday  10:00 AM - 11:30 AM

      Fremont, California, United States
      Fremont, California

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      Implementing a Compliant Stability Program for Biologics

      Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.

      Why should you Attend:
      To collect data that supports expiry dating, the drug substance and the drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and interpretation of the data is necessary for personnel involved in product development, product testing, and product release.

      Areas Covered in the Session:
      Testing CQAs
      Stability Indicating Methods
      Test conditions, including stress conditions
      Data requirements
      Considerations for expiry dating

      Who Will Benefit:
      Laboratory Scientists
      Laboratory Managers
      Quality Assurance Specialists
      Quality Control Specialists

      Speaker Profile:
      Gwen Wise-Blackman, Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise.

      Event Fee: One Dial-in One Attendee Price: $150.00

      Contact Detail:
      Compliance4All DBA NetZealous,
      Phone: +1-800-447-9407

      Cost: Payment required - $150 Live

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.