RAPS: This course has been pre-approved by RAPS as eligible for up to 10.0 credits towards a participant's RAC recertification upon full completion.
This online training course provides a comprehensive and practical understanding of Batch Record Design, Documentation, and Review in compliance with FDA, EMA, and EU GMP requirements. Regulatory agencies require every manufacturer to maintain written procedures that document production and process controls - collectively known as batch records. Additionally, there must be formalized procedures for batch record review to ensure accuracy, traceability, and compliance with global quality standards.
A well-structured Batch Record Review (BRR) system is essential for capturing and verifying all critical process parameters associated with the manufacturing of pharmaceuticals, biologics, and medical devices.
Through real-world examples and case studies, this course demonstrates best practices in designing and maintaining inspection-ready batch records. Participants will learn how to identify and correct documentation errors, implement robust review workflows, and maintain data integrity across all stages of production.
This accredited training also covers Master Batch Records (MBRs), regulatory requirements, and the key steps involved in issuance, reconciliation, review, and final QA disposition.
By the end of the course, attendees will understand how to design, document, and review batch records that meet global regulatory expectations while improving efficiency, quality, and compliance.
Course Content
Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System
- Global regulations and expectations
- Regulations Update and Latest Developments in Industry
- How documentation fits into the Quality System of recommendations and regulations
- Important data for Quality Assurance
- Risk Assessment and Continuous Improvement
The Design of the Master Batch Documentation
- Is there a need for re-design?
- Important aspects to consider
- How to gain efficiency
Efficiency in Batch Record Review
- Layout and handling
- How to reduce review time: examples
- How to handle and document deviations
- How to present review results to the QP
- Balanced Score Card
- KPIs
Risk Assessment/ Management Applications within the Batch Record Process
- How the risk lifecycle links with the BRR stages:
- Risks associated with paper and electronic records
- Risks associated with people checking documentation
- Relative risk factors
- Risks associated with the process
- Risks for QP 'discretion'
- Quality Risk Management
- Impact the effectiveness of deviations, OOS and
Change Controls
- Improvement of root cause investigations
- Using QRM to perform a SWOT analysis
- What does a good risk assessment look like?
QA Oversight on EBR validation activities
- Validation Life Cycle
- Qualification activities
- Maintenance
- Training
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. 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.
Who Should Attend
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
It will be especially valuable to the personnel and management, including senior management, in these areas:
- Quality Assurance (QA) & Quality Control (QC) Professionals
- Manufacturing & Production Managers
- Regulatory Affairs Specialists
- Batch Record Reviewers & Documentation Teams
- Validation & Compliance Officers
