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.
This accredited training will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition.
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
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
- Quality Control
- Facilities
- Manufacturing
- Validation Professions in GMPs and Pharmaceuticals
