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Reviewing Drug Product Batch Records - Webinar

  • Webinar
  • 60 Minutes
  • March 2022
  • Compliance Online
  • ID: 5449087

Why Should You Attend:


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.

Agenda

  • 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

Who Should Attend

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