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Regulatory Talks: Finalization of USP <665>



WEBINAR

The principle scientific liaison from the United States Pharmacopeia (USP) will clarify details regarding the first compendial general chapter, USP <665>, detailing a standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing. This discussion will focus on the shift to this new approach and the necessity to conduct previous compendial test methods.

The expert panel will examine USP <665> in relation to other plastic qualification approaches. This discussion will include details regarding shifting away from USP <661>, along with questioning the necessity of other related general chapter methods. Specifically, USP <661.1> and <661.2> will be highlighted, which are typically utilized for material characterization and drug packaging component characterization, respectively. In the end, you will be more confident in understanding what, how, and when best to utilize the new compendial USP <665> standard extractables test methods.

In this webinar, you will:

  • Understand details regarding the first official compendial general chapter, USP <665> for plastic components and systems used in drug manufacturing
  • Learn about the scope and justification to help you eliminate the need for previous testing methods which are no longer directly relevant
  • Leverage expert knowledge and regulatory support to plan the best approach to transition to this new USP <665> compendial extractables testing standard

Speakers

Janmeet Anant, Ph.D.

Janmeet Anant, Ph.D.

Merck

Senior Regulatory Consultant

Janmeet Anant is a senior regulatory consultant, focused on biopharmaceutical manufacturing at Merck. Janmeet serves as an executive board member for the Bioprocess Systems Alliance (BPSA) and a member of the Regulatory Governance Team at BioPhorum.

He has more than 20 years of experience, moving through technical application roles for chromatography, filtration, cell culture and, most recently, regulatory consulting. Janmeet has a B.S. in Chemistry and a Ph.D. in Pharmacology.

Monica Cardona

Monica Cardona

Merck

Senior Program Manager

Monica Cardona is a senior program manager for single-use and integrated systems at Merck. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing.

Monica holds a B.S. in Biology from Hofstra University and an M.S in Biology from Adelphi University. She has published and lectured internationally on a wide range of filtration, validation, and single-use bioprocessing topics. Monica is a member of the Parenteral Drug Association (PDA), BioPhorum, and a founding member of Bio-Process Systems Alliance (BPSA).

Desmond Hunt, Ph.D.

Desmond Hunt, Ph.D.

United States Pharmacopeia (USP)

Principle Scientific Liaison

Desmond G. Hunt, Ph.D. is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise standards at the United States Pharmacopeia (USP).

He has authored many publications, is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He also participates on industry Working Groups and Technical Committees. Desmond obtained his M.S. and Ph.D. from the University of Texas at Austin.

Webinar Information

Pharma and biopharma manufacturing

  • Compendial Testing and Regulatory Guidance
  • Duration:1hr

  • Language:English

  • Presented:Thu, February 17, 2022

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