If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: firstname.lastname@example.org
Dr Bernhard Böhm
McGee Pharma International
Dr Monika Schlapp
During this course, you will learn all relevant aspects to conduct and to improve your system of the Batch Record 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 released by a Qualified
Person. However, over the years, documentation has
become more and more extensive and the review can
be very time-consuming.
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
During this Education Course, experts from the pharmaceutical and API industry will cover all relevant aspects helping you to improve your batch record review. An optimised batch record review will also enable you to improve your process capabilities.
This Education Course is designed for all persons in
Production and Quality Units who deal with the review of 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
ICH Q7 requirements
Regulations Update and Latest Developments in Industry
How documentation fits into the Quality System of recommendation and regulations
Important data for Quality Assurance
Risk Assessment and Continuous Improvement
How to handle the Documentation:
Batch Documentation Life Cycle
Creation/change of master documents
Collection of records
Archiving and retrieval
- Electronic systems
- Hybrid systems
The Design of the Master Batch Documentation
Is there a need for re-design?
Important aspects to consider
How to gain efficiency
Steps to consider for a successful Batch Record
Changes during the process
Deviations in production
Certificates of analysis
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
Summary and Take Away Message
How to structure reviews
Different assurance approaches in review
Responsibilities for review
Case Study: Electronic Batch Record – a competitive Advantage?
Transition paper based to EBR
How efficient is a EBR system?
Challenges in the introduction phase of EBR
Electronic Batch Record Review by EBR
Two Case Studies on Operational Excellence: Tools to reduce Batch Record Review Time
History of Operational Excellence
Tools and philosophy
The project: batch record work stream reduction
How to successfully execute Kaizen events
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:
Deviation Management and Failure Investigation as Part of the Batch Record Review
How to optimize your Batch Record Review flow: The way from status quo to an ideal state
Organisation of a Batch Record Review
Each participant will have the opportunity to take part in 2 workshops! Please choose the ones you like to attend when you register for the course.