Dr Bernhard Böhm
Boehringer Ingelheim Vetmedica
Referierende
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
Zielgruppe
- 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
Zielsetzung
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.
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.
Programm
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
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)
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
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
Weitere Informationen
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
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.
Contacts
Questions regarding content:
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.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation etc.:
Ms Sarah Schmidt, +49 6221 84 44-16, s.schmidt@concept-heidelberg.de
Questions regarding organisation etc.:
Ms Sarah Schmidt, +49 6221 84 44-16, s.schmidt@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 23 June 2027, 09:00–17:30 h
(Registration and coffee 08:30–09:00 h)
Thu, 24 June 2027, 08:30–15:45 h
Thu, 24 June 2027, 08:30–15:45 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| European 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
Teilnehmerstimmen - das sagen andere über unsere Seminare:
