Dr Bernhard Böhm
Boehringer Ingelheim Vetmedica
Referent:innen
Ingo Ebeling
Abbott Laboratories
Dr Monika Schlapp
Boehringer Ingelheim Vetmedica
Jakub Cierny
SOTIO Biotech
Dr Felix Kern
Merck Healthcare
Zielsetzung
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.
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.
Date & Venue
Date
Tuesday, 29 April 2025, 9.00 h – 17.30 h
(Registration and coffee 8.30 h – 9.00 h)
Wednesday, 30 April 2025, 8.30 h – 15.30 h
Tuesday, 29 April 2025, 9.00 h – 17.30 h
(Registration and coffee 8.30 h – 9.00 h)
Wednesday, 30 April 2025, 8.30 h – 15.30 h
Venue
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
Phone +49 (0) 40/ 22 63 62 0
hamburg@barcelo.com
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| QP Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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