COURSE ID 2752

Introduction to Batch Record Review

AVAILABLE ON-DEMAND
Duration: 60 Minutes
Course Instructor

Laura Jeannel

Price
$ 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 in order 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 training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, 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 upon 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 personnel and management, including senior management, in these areas:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Facilities
  • Validation

Course Instructor

Laura Jeannel

Senior Quality Consultant, Farbridge Pharma Consulting

Laura Jeannel’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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