Bob McDowall, McDowall Ltd., UK
Stephan Dresen, Warner Chilcott Deutschland GmbH/An Allergan Company, Germany
Wolfgang Schumacher, formerly F. Hoffmann-La Roche
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.
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 form.
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.
Overview of the Training Seminar
Data Integrity Principles
Current Inspection Observations and Their Potential Resolution
- Basements of Data Integrity
- Implementation of Data Integrity Standards at a Side (Praxis Example)
- CARs Model (Critical Application Risks) – an implementation model based on Quality Risk Management
Why is control of blank forms important?
- Examples from current Inspections
- Potential CAPAs on observations
- Watch-Outs and defense packages
- Inspectors expectations on industry from different authorities: FDA, ANVISA, MHRA, German MoH …
Facilitated Discussion: Control of Templates and Blank Forms
Records – Life Cycle and data integrity issues
- Instructions and blank forms – Life cycle and data integrity considerations
- FDA requirements for control from 1993 and 2016
- Process for creation of master templates
- Process for operational use of blank forms
- Reconciliation mechanisms
GMP-compliant document change management
- GMP Record Lifecycle
- Control Mechanisms
- Data Integrity for physical vs. electronic Records
- How to manage record copies without violating DI rules?
Advantages and Disadvantages of Document Management Systems: Paper based - Hybrid - Electronic
Electronic Document Management and Change Control Systems to Ensure Data Integrity
- How to establish a compliant and pragmatic change control process?
- The GMP Document Roadmap
- Document inventory and reconciliation
- Industry best practice for Record retention timelines – GMP requirements vs. Knowledge Management
Data Integrity and digital signatures
- 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
- Mapping ALCOA principles on EDMS and Change Control
- Expectations from Inspections
Handling hybrid records: Good Documentation Practices for linked paper and electronic records
- What exactly is an electronic signature?
- Advanced vs qualified digital signature
- Technical implementation
- Change of Workflows
- Parallel processes
- How to manage replacements
Second Person Review of Batch and analytical records: - paper, hybrid and electronic formats
- 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 is linked to the record
- Common pitfalls in record-signature linking
How to train staff in Good Documentation Practice and Data Integrity
- 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
Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
- 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
Typical documentation failures and how to avoid them – key learning points
Management and Control of multilingual Documents (Data Integrity Expectations)
- Analysis of FDA 483 and warning letter citations for poor documentation practices
- Identification of top 5 documentation failures
- Ways to avoid them e.g. through changes in working practice, training and technical controls
Workshop: Design of a Document Control SOP
- Part 1: Basics: Workbench, Translation, Synchronisation
- Part 2: Implementation and Management Responsibilities, GMP status, Versions, Signatures, Change Control