17-04-2025
Efficient Batch Record Design and Review Certificate Course: Paving the Way for Enhanced Efficiency in Regulatory Compliance (ONLINE EVENT: May 7-8, 2025 & ON-DEMAND)
DUBLIN--(BUSINESS WIRE)--Apr 17, 2025--
The 'Efficient Batch Record Design and Review Certificate Course' training has been added to offering.
This online training is designed for professionals in the Pharmaceutical, Medical Device, and other life science industries. This Education Course is designed for all persons in Production and Quality Units who deal with the design and review of batch documentation in pharmaceutical, biopharmaceutical and API production. It is also addressed to Qualified Persons who want to improve their system of the batch record review.
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.
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.
In this 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.
It will be especially valuable to the personnel and management, including senior management, in these areas:
Key Topics Covered:
Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System
The Design of the Master Batch Documentation
Efficiency in Batch Record Review
Risk Assessment/ Management Applications within the Batch Record Process
Change Controls
QA Oversight on EBR validation activities
Speakers:
Kelly Thomas
Vice President
Stallergenes Greer
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
For more information about this training visit
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KEYWORD:
INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE PHARMACEUTICAL HEALTH MEDICAL DEVICES EDUCATION TRAINING OTHER HEALTH
SOURCE: Research and Markets
Copyright Business Wire 2025.
PUB: 04/17/2025 08:24 AM/DISC: 04/17/2025 08:24 AM
