Dr Bernhard Böhm, Boehringer Ingelheim
Jakub Cierny, SOTIO a.s.
Ingo Ebeling, Abbott Laboratories
Dr Monika Schlapp, Boehringer Ingelheim Vetmedica
Roger Smith, Redwood Pharma Consulting
During this course, you will be able to discuss all relevant aspects of the batch record flow from the master to the review. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.
The Batch Record Review is an essential tool for assuring the quality of a pharmaceutical process.
Various regulations and guidelines address this topic for the pharmaceutical industry and it is a very important step before a product can be certified by a Qualified Person. However, over the years, documentation has become more and more extensive and the review can be very time-consuming, also because of complex master documents.
Furthermore, many observations made in inspections relate directly to the review of batch records. This fact clearly demonstrates the importance and challenge of implementing a GMP/ FDA-compliant batch record design and review. During this Education Course, experts will cover all relevant aspects helping you to improve your batch records and their review.
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 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
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
- Operational Excellence - Tools to reduce Batch Record Review Time
- Electronic Batch Record (EBR) – a competitive Advantage?
- Serialisation - from Master Batch Documentation to Batch Release
- Failure Investigation
- Design of a Master Batch Documentation/ Protocol
- Batch Record Design and Review in pharmaceutical Development