EU and US Drug Product Batch Records Review Webinar 2022 – ResearchAndMarkets.com

EU and US Drug Product Batch Records Review Webinar 2022 – ResearchAndMarkets.com




EU and US Drug Product Batch Records Review Webinar 2022 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Reviewing Drug Product Batch Records” webinar has been added to ResearchAndMarkets.com’s offering.

Batch record review is a GMP requirement. Furthermore, trending of manufacturing data facilitates continuous product improvement, which is the focus of a pending ICH guidance document (ICH Q12). Pharmaceutical manufacturers will be expected to demonstrate that their manufacturing processes continue to produce medicinal products of a consistently high quality.

Batch records can also be used to identify sources of manufacturing variability, enabling improvements to be made to the production method. This webinar details current regulatory expectations and sets out a logical approach for batch record review. Methods for trending batch data will also be discussed. In addition to understanding regulatory expectations, you will learn how to use batch records as tools to facilitate continuous improvement.

Who Should Attend:

  • Production staff
  • Production management
  • Quality assurance professionals
  • Qualified persons (EU)
  • Regulatory affairs professionals

Key Topics Covered:

  • Regulatory requirements for batch review (EU and US)
  • Important areas to check in batch records
  • Common errors
  • Examples of deficiencies leading to regulatory enforcement action
  • Overview of the draft ICH Q12 guidance
  • ICH Q12 and Quality by Design
  • Benefits of continuous improvement
  • Approaches to data trending

For more information about this webinar visit https://www.researchandmarkets.com/r/uiq35l

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900