Introduction to Batch Record Review

Date(s) and Time:
July 25, 2024
11 am EDT - 12 pm EDT
Duration: 60 Minutes

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Laura Jeannel

Early-Bird Offer

Limited Availability until July 12, 2024

$ 175
$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance. A strong batch record review system is essential to properly document all critical and operational process parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.

In this introductory accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition. Several examples and case studies of best practices will be demonstrated to emphasize how an effective batch record review is conducted based on current quality/regulatory requirements.

Upon completion of this course, you will be able to:

  • Define Master Batch Record and its contents
  • Identify MBR regulatory requirements
  • Show Effective Batch Record Review
  • Demonstrate effective turnaround time for Batch Record Review for in-house and CMO oversight
  • Outline Responsibilities for QA Disposition, oversight, and continuous improvement.

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This entry-level online training is designed for professionals in the Pharmaceutical, Medical Device, and other life science industries.

It will be especially valuable to the personnel and management, including senior management, in these areas:

  • Quality Assurance
  • Quality Control
  • Facilities
  • Manufacturing
  • Validation Professions in GMPs and Pharmaceuticals

Course Instructor


Laura Jeannel

Senior Quality Consultant, Farbridge Pharma Consulting

Laura Jeannel’s Courses


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