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Overcoming Quality and Regulatory Challenges of Implementing Single-Use Pharmaceutical Manufacturing



WEBINAR

Single-use pharmaceutical manufacturing has been widely adopted in development and clinical manufacturing. Even though these disposable technologies offer various benefits, there are still some challenges based on a lack of standardization of quality tests and procedures.

In this webinar you will learn :

  • Current and upcoming industry and regulatory requirements for single-use pharmaceutical manufacturing systems
  • Detailed compatibility requirements, including extractables/leachables, particulates, integrity, and supplier change control standard proposals
  • Quality and regulatory documentation based on these requirements, making the implementation of single-use systems more efficient

Speaker

Janmeet Anant, Ph.D.

Janmeet Anant, Ph.D.

MilliporeSigma

Senior Regulatory Consultant

Janmeet Anant is a senior regulatory consultant, focused on biopharmaceutical manufacturing at MilliporeSigma. 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.

Webinar Information

Pharma and biopharma manufacturing

  • Downstream Processing
  • Duration:58min

  • Language:English

  • Presented:Thu, February 16, 2017