Batch Manufacturing Documents: from Preparation to Operational Excellence
23/24 June 2027, Berlin, Germany
Course No. 22860
Speakers
Dr Bernhard Böhm
Boehringer Ingelheim Vetmedica
Ingo Ebeling
Abbott Laboratories
Dr Monika Schlapp
Boehringer Ingelheim Vetmedica
Jakub Cierny
SOTIO Biotech
Dr Felix Kern
Merck Healthcare
Maria Thai Hien Nguyen Heimbürger
Ascendis Pharma
On-site with two Workshops and several Q&A Sessions
Target Group
Professionals in Production and Quality units involved in the creation, maintenance, and review of batch documentation for pharmaceutical, biopharmaceutical, and API manufacturing
Qualified Persons (QPs) seeking to strengthen and streamline their batch record review process
Objectives
Gain a comprehensive understanding of the batch record workflow—from the master batch record through execution to batch record review. You will also learn about practical options and tools to increase efficiency and reduce review effort and costs in your company.
Background Batch record review is a key element of pharmaceutical quality assurance and a critical step prior to batch certification by the Qualified Person (QP). A range of regulations and guidelines address batch documentation and review requirements. Over the years, however, batch documentation has become increasingly extensive, and reviews can be time-consuming—particularly when master documents are complex.
Programme
Highlights
Background and GMP Requirements
Practical Implementation
Process Improvement
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 Studies)
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 (Presentation and Workshop)
MBR Design and Approval
Ways to optimise
Responsibilities
Paper based vs electronical MBR
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 to optimise your Batch Record Review Flow (Presentataion 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
AI as a Tool for Master Batch Record Design and Executed Batch Record Review
AI applications in Batch Record Design
AI in Batch Record Review
Limitations and challenges
Future outlook
Further Information
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin Germany +49 30 2127-714 info@doubletreeberlinkudamm.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG after registering for the course. Reservations should be made directly with the hotel. Early booking is recommended.
Get-Together On 23 June, you are cordially invited to a Get-Together including Dinner. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate plus VAT) ECA Members EUR 1,890
EQPA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments.VAT is reclaimable.
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.
Conference language The official conference language will be English.
Testimonials
