Efficient Batch Record Design and Review
Vienna, Austria
Course No 16768
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Bernhard Böhm, Boehringer Ingelheim
Jakub Cierný, SOTIO a.s.
Ingo Ebeling, Abbott Laboratories
Dr Monika Schlapp, Boehringer Ingelheim
Roger Smith, Redwood Pharma Consulting
Objectives
During this course, you will learn 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.
Background
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.
Furthermore, many observations made in inspections relate directly to the review of documents. This fact clearly demonstrates the importance and challenge of implementing a GMP/FDA-compliant Batch Record Review.
During this Education Course, experts will cover all relevant aspects helping you to improve your batch records and their review.
Target Group
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.
Workshops
Three parallel workshops will be conducted in order to deepen the content of the lectures and to discuss practical aspects in detail.
Workshops will be offered on the following topics:
Workshop 1
Deviation Management and Failure Investigation as Part of the Batch Record Review
Workshop 2
How to optimise your Batch Record Review flow: The way from status quo to an ideal state
Workshop 3
Design of a Master Batch Documentation/Protocol
Each participant will have the opportunity to take part in TWO workshops!
Please choose the ones you like to attend when you register for the course.
Programme
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
- Is there a need for re-design?
- Important aspects to consider
- How to gain efficiency
- Review Preparation
- Line clearance
- Process steps
- Changes during the process
- Deviations in production
- Certificates of analysis
Serialisation - from Master Batch Documentation to Batch Release
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
- Transition from paper based to EBR
- Master approval
- How efficient is an EBR system?
- Challenges in the introduction phase
- Electronic Batch Record Review
- Validation Life Cycle
- Qualification activities
- Maintenance
- Training
- Tools and philosophy
- Batch record work stream reduction
- How to successfully execute Kaizen events
- Re-Design of batch records
- Right first time project
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