Efficient Batch Record Design and Review

Efficient Batch Record Design and Review

Berlin, Germany

Course No 15218


Costs

This conference already took place.

If you have any questions, please contact us:
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.

Programme

Regulatory Requirements applying to Batch Record
Review, Pharmaceutical Documentation & the Quality System
EU Regulations
FDA
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
Distribution
Collection of records
Archiving and retrieval
Solutions for
- Paper
- 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
Review Preparation
Line clearance
Process steps
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
KPIs

Case Study: Electronic Batch Record – a competitive Advantage?
Transition from paper based to EBR
Master approval
How efficient is an EBR system?
Challenges in the introduction phase
Electronic Batch Record Review

Two Case Studies on Operational Excellence: Tools to reduce Batch Record Review Time
Tools and philosophy
Batch record work stream reduction
How to successfully execute Kaizen events
Re-Design of batch records
Right first time project

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 optimize your Batch Record Review flow: The way from status quo to an ideal state

Workshop 3
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.

Summary and Take Away Message
How to structure reviews
Different assurance approaches in review
Responsibilities for review

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