Updates of the new Chapter 4, Annex 11 and USP 1029!
Target Group
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.
Objectives
During this Course you will get to know the principles of Good Documentation Practices in the light of Data Integrity requirements.
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.
Background
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.
Programme
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
Further Information
Venue HYPERION Hotel München Truderinger Straße 13 81677 Munich, Germany Phone +49 89 4110 900 Email hyperion.muenchen@h-hotels.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The fee is payable in advance after receipt of invoice and includes lunch/business lunch on all 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.
Tuesday, 14 April 2026, 9:00 – 17:30 h (Registration/coffee 8.30 – 9.00 h) Wednesday, 15 April 2026, 9:00 – 16:30 h Thursday, 16 April 2026, 9:00 – 13:45 h
Testimonials
