Dr Bob McDowall
R.D. McDowall Ltd.
Referent:innen
Dr. Stephan Dresen
Daiichi Sankyo Europe
Dr Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Updates of the new Chapter 4, Annex 11 and USP !
Zielsetzung
During this Course you will get to know the principles of Good Documentation Practices in the light of Data Integrity requirements.
You will learn
You will learn
- How to control blank forms and templates
- How to maintain Data Integrity for physical, hybrid and electronic records
- How to establish a compliant and pragmatic change control process
- How poor documentation practices and falsification can be detected
- How to train staff in Good Documentation Practice and Data Integrity
- How multilingual documents can be managed and controlled
- How to avoid typical documentation failures
Experts will show what you need to consider to maintain GMP- compliant documentation systems throughout their life cycle.
Hintergrund
Despite numerous regulatory guidelines poor documentation practice has become more and more a global problem and in most cases it leads to severe violations of Data Integrity principles. The citations regarding Data Integrity issues in FDA warning letters have been increasing dramatically over the past 3 years and also European Regulatory Agencies are concerned about Data Integrity failures in poor documentation not only in companies located in far East but also within Europe.
Both FDA and UK’s MHRA have reacted to this situation by issuing guidances containing clear provisions regarding Data Integrity and documentation e.g. FDA’s CPG objective 3 which covers the laboratory Data Integrity audit or MHRA’s Guidance for Industry on Data Integrity. Also WHO has published a guidance which provides provisions for data governance and contains expectations for records in both paper and electronic forms.
Both FDA and UK’s MHRA have reacted to this situation by issuing guidances containing clear provisions regarding Data Integrity and documentation e.g. FDA’s CPG objective 3 which covers the laboratory Data Integrity audit or MHRA’s Guidance for Industry on Data Integrity. Also WHO has published a guidance which provides provisions for data governance and contains expectations for records in both paper and electronic forms.
Zielgruppe
This Education Course is designed for managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies and API manufacturers. Laboratory and QA personnel from Contract Research Organisation and Contract Manufacturing Organisations as well as auditors responsible for performing self-inspections or external audits will also benefit from this course.
Date / Venue /Presentations / Certificate
Date
Date
Tuesday, 14 April 2026, 9.00 – 17.30 h
(Registration and coffee 8.30 – 9.00)
Wednesday, 15 April 2026, 9.00 – 16.30 h
Thursday, 16 April 2026, 9.00 – 13.45 h
All Times mentioned are CEST.
Venue
HYPERION Hotel München
Truderinger Straße 13
81677 Munich, Germany
Phone +49 89 4110 900
Email hyperion.muenchen@h-hotels.com
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.
Programm
Gesamtes Programm als PDF herunterladen
Data Integrity Principles
- Basements of Data Integrity
- Guidelines
- Implementation of Data Integrity Standards at a Site (Praxis example)
- CARs Model (Critical Application Risks) – an implementation model based on Quality Risk Management
Updates to EU GMP Chapter 4 (Documentation) and Annex 11 (CSV)
- Changes to Chapter 4 and Annex 11 for paper and computerised Systems
- Elements of the required Data Governance System
- Control of raw data
- Data integrity, validation and system security topics
- Automated validation and testing – really saving costs and efforts?
Current Inspection Observations and their Potential Resolution
- Examples from current inspections
- Potential CAPAs on observations
- Watch-Outs and defense packages
- Inspectors expectations from different authorities: FDA, ANVISA, MHRA, German MoH …
Why is Control of Blank Forms Important?
- Instructions and blank forms – Life cycle and Data Integrity considerations
- FDA requirements for control
- Process for creation of master templates
- Process for operational use of blank forms
- Reconciliation mechanisms
Facilitated Discussion: Control of Templates and Blank Forms
Records and Life Cycle and Data Integrity Issues
- Record and data Lifecycle
- Understanding complete data / information and raw data
- Controls for paper and electronic records
- Scanning and destroying paper records
Electronic Document Management and Change Control Systems to Ensure Data Integrity
- Data Integrity expectations on an Electronic Document Management System (EDMS) and Change Control System
- Audit Trail Review / Log File Review
- Fundaments of a modern EDMS
- Traceability
- Mapping ALCOA principles on EDMS and Change Control
- Expectations from inspections
Data Integrity and Digital Signatures
- What exactly is an electronic signature?
- Advanced vs qualified digital signature
- Technical implementation
- Change of Workflows
- Parallel processes
- How to manage replacements
Handling Hybrid Records: Good Documentation Practices for Linked Paper and Electronic Records
- Chapter 4 and 21 CFR 11 regulations for linking signatures to electronic records
- Are you saving the underlying electronic record?
- Checks and technical controls to ensure the signature are linked to the record
- Common pitfalls in record - signature linking
USP<1029> Good Documentation Guidelines and Data Integrity
- Review of the draft update to the general chapter
- Identification of the proposed changes
- Data integrity and ALCOA++ criteria are now within scope
- Problems with the current and draft update of USP <1029>
Second Person Review of Batch and Analytical Records: Paper, Hybrid and Electronic Formats
- Importance of a second person review for Data Integrity
- What will a reviewer review with paper, hybrid and electronic records?
- Training for second person review
- Detection of poor documentation practices and falsification
- Risk-based second person reviews of records and audit Trails
Workshop:
- Document Control Process Flow
- Identify the Dos and Don‘ts for both paper and electronic records
How to Train Staff in Good Documentation Practice and Data Integrity
- Pre-requisites: Data Integrity policy with effective Training
- Procedure for good documentation practices is essential
- Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding
Data Integrity: Praxis Example of Implementation of the Requirements at a Pharma Site Based on Quality Risk Management Principles
Typical Documentation Failures and how to Avoid them – Key Learning Points
- Learning from the worst: the FDA annual list of 483 observations
- Identifying the top 5 documentation failures from the list
- Suggestions to avoid getting a citation in your facility
AI / LLM tools with regard to Data Integrity and GxP Regulations
- Introduction to LLM-based AI systems in pharma
- Practical use cases for LLMs in regard to Data Integrity and GxP
- Regulatory landscape and new guidance (incl. drafts)
- Data Integrity considerations for AI Systems
- Validation and compliance challenges
- Limitations and risks of LLM applications
- Outlook and strategic considerations
Management and Control of Multilingual Documents (Data Integrity Expectations)
- Part 1: Basics
- Workbench
- Translation
- Synchronisation - Part 2: Implementation and Management
- Responsibilities
- GMP status
- Versions
- Signatures
- Change control
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
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
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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E-Mail: info@concept-heidelberg.de
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