Efficient Batch Record Design and Review

29/30 April 2025, Hamburg, Germany

Course No. 21538

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Speakers

Dr Bernhard Böhm

Dr Bernhard Böhm

Boehringer Ingelheim Vetmedica

Jakub Cierny

Jakub Cierny

SOTIO Biotech

Ingo Ebeling

Ingo Ebeling

Abbott Laboratories

Dr Monika Schlapp

Dr Monika Schlapp

Boehringer Ingelheim Vetmedica

Dr Felix Kern

Dr Felix Kern

Merck Healthcare

Objectives

During this live Education Course, you will hear about 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.

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.

Presentations/Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.

After the event, you will automatically receive your certificate of participation.

Programme

Efficient Batch Record Design and Review

Seminar Programme as PDF

Part 1: Background and GMP Requirements
 
Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System
  • Part 1: Batch Record Review
    - Cost of Quality
    - Relevant GMP Guidelines: EU, US, ICH
    - Regulations update with impact on documentation
    - Documentation and FDA Warning Letters
  • Part 2: Pharmaceutical Documentation and the Quality System
    - How batch documents fit into the Quality System
    - Important data for Quality Assurance
    - Risk Assessment and continuous improvement
    - The link to Operational Excellence and validated automated systems
    - Review Matrix
    - Possible structures
The Design of the Master Batch Documentation
  • Important aspects to consider
  • How to gain efficiency
Batch Record Design and Review in pharmaceutical Development (Case Studies)
  • Differences from the commercial batch records
  • Expectations from batch record in development
  • Different scenarios (stucture, deviation, changes, training, review process)
Part 2: Practical Implementation
 
From the MBR Design to final Approval (Presentation and Workshop)
  • MBR Design and Approval
  • Ways to optimise
  • Responsibilities
  • Paper-based vs electronical MB
  • Examples
Part 3: Possibilities for Process Improvement

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
Operational Excellence Tools to reduce Batch Record Review Time
  •  Background
  •  How to use Kaizen
  •  Project: “Batch record reduction / flow optimization”
How wo optimise your Batch Record Review Flow (Presentation and Workshop)
  • The way from status quo to an ideal state
Electronic Batch Record – A competitive Advantage?
  •  Legal background
  •  Minimum requirements
  •  What needs to be considered?
  •  Advantages
  •  Case Study
QA Oversight on EBR Validation Activities
  • Validation Life Cycle
  • Qualification activities
  • Maintenance
  • Training

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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-
QP Member Discount*: € 1690,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

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“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023