Dr Berhnard Böhm
Boehringer Ingelheim Vetmedica
Referent:innen
Jakub Cierny
SOTIO Biotech
Ingo Ebeling
Abbott Laboratories
Dr Monika Schlapp
Boehringer Ingelheim Vetmedica
Dr Felix Kern
Merck Healthcare
All times mentioned are CET.
Zielsetzung
During this live online 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.
Hintergrund
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.
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.
Zielgruppe
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.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Part 1: Background and GMP Requirements
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
Batch Record Design and Review in pharmaceutical Development (Case Study)
- Differences from the commercial batch records
- Expectations from batch record in development
- Different scenarios
Part 2: Practical Implementation
From the MBR Design to final Approval
- Creation of the Master Batch
- Generation of the batch documentation (who, what, how)
- The path through production.
- Review process (who, what, how)
- QP involvement
- Site kick: what if individual process steps take place at a third party
- 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”
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
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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