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Course No 16768

Efficient Batch Record Design and Review

28-29 May 2019, Vienna, Austria


Costs:
Non-ECA Members: EUR 1.690,--
ECA Members: EUR 1.490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1.590,--
QP Association Members: EUR 1.490,--
(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

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



Learning 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
  • 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
Steps to consider for a successful Batch Record
  • Review Preparation
  • Line clearance
  • Process steps
  • Changes during the process
  • Deviations in production
  • Certificates of analysis
Case Study:
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
Case Study: Electronic Batch Record (EBR) – 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
QA Oversight on EBR validation activities
  • Validation Life Cycle
  • Qualification activities
  • Maintenance
  • Training
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 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.

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