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

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

Webinar

Abstract

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, incl. 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.

Merck

Regulatory Affairs Advocate

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Merck

Research. Development. Production.

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