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xtalks.com, webinar
Thursday, February 10, 2022 | 11am EST (NA)
Who Should Attend?- General Managers or Site Heads
- Directors, VPs, or Managers of Manufacturing
- Technical Service and Technical Transfer Groups
- Pharmaceutical Development Groups
- Operations and Facility Personnel
- Quality Engineering and Quality Assurance Teams
- Environmental, Safety, and Health Groups
What You Will LearnRegister for this webinar to learn about: - High-level overview of the scale-up and qualification process for new product launch
- Common issues that arise between registration and qualification (scale-up)
- Risk-based approaches to mitigating scaleup issues prior to registration — evaluating process robustness
- What data to collect and evaluate during registration batches
- Other considerations for registration manufacturing
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Organized by:
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xtalks.com |
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Invited Speakers:
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SpeakersHarry G. Cocolas, PhD., Senior Director of Technical Services, Mayne PharmaAs senior director of Technical Services for Mayne Pharma US, Harry is responsible for overseeing all activities related to the transfer of products into commercial manufacturing and technical support of ongoing commercial production. He holds a BS in pharmacy from the University of North Carolina and masters and doctorate degrees in pharmaceutical science from Rutgers University. Message PresenterKyle D. Fugit, PhD., Associate Director, Technical Transfer, Mayne PharmaAs associate director of Technical Services for Mayne Pharma US, Kyle is responsible for evaluating new project opportunities and the transfer of products into commercial manufacture developed internally by Metrics Contract Services’ pharmaceutical development and from external manufacturing sites. He holds a BS in chemical engineering from the University of Alabama and a doctorate degree in pharmaceutical science from the University of Kentucky. Message PresenterAnshul Gupte, PhD., RAC, Senior Director, Scientific and Technical Affairs, Metrics Contract ServicesAs senior director of scientific and technical affairs, Anshul is responsible for the technical and scientific oversight of client projects at Metrics Contract Services. He works across various functional teams in RFP considerations and scope of work development, proposal delivery and client meetings. Anshul holds a Bachelor of Pharmacy from the RGPV University, Bhopal, India, a Master of Science in Pharmaceutical Sciences from Temple University, and a Doctorate in Pharmaceutical Sciences from the University of Kentucky. |
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Deadline for Abstracts:
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na
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Registration:
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https://xtalks.com/webinars/transitioning-from-clinical-to-commercial-manufacturing-part-1-preparing-for-registration/
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E-mail:
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shunte@xtalks.com
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