Frank Behnisch, CSL Behring GmbH, Germany
Dr David Selby, Selby Hope International, UK
Dr Robert Stephenson, Rob Stephenson Consultancy, UK
This is why you should attend this course:
You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
You have the opportunity to practically apply the theoretical foundations in 7 workshops
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the education course will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
This course is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.
Introduction –What the Participants Expect
Laws, Regulations and Guidelines for Computer Validation
- An open session capturing the expectations of the delegates
Electronic Records and Signatures
- The historical perspective
- Current regulations and regulatory guidelines from US
- New regulatory guidance (GAMP® 5, GAMP® Good Practice Guides, ASTM)
- New industry guidance
- Regulatory training
The EU Annex 11 “Computerised Systems”
- What Part 11 means – Now!
- Identify e-records in predicate rules
- Identify risks to records
- Identify appropriate controls for records
The GAMP® 5 Approach to Computer Validation
- What is new?
- What are the important points?
- How can you implement it?
Risk Management – A Key Point Review
- Validation needs structure
- The GAMP® approach
- What is new in GAMP® 5
- General validation activities
- The GAMP® Categorisation System
- Life Cycle cost reduction
- How to use the FMEA tool to reach better risk-based decisions?
- Risk registers
- Documenting risk
- How to make use of risk information
Programme 2nd Day
Specifications, Design Review and Traceability
- Why is a validation plan important?
- Definitions and regulatory expectations
- Building risk management into planning phase
- Structure and contents of validation plans
- Discussion of best approach
- The impact of scaleability
Protocols, Test Scripts and Deviation Management
- What sorts of specifications are needed?
- How are they constructed?
- Can they be combined?
- How to carry out a design review?
- How to construct a traceability matrix?
- Principles of Risk-Based Qualification
- Leveraging the Supplier
- Commissioning vs Qualification
- Test Script Design
- Deviation Management
- Regulatory requirements
- Configuration management
- Planned/unplanned changes
- Sources of changes
Programme 3rd Day
Validation Reporting & Presentation to Inspectors
- System Overview
- GAMP® and risk analysis
- Qualification / Validation
Introduction to IT-Infrastructure Qualification
- The link between the plan and the report
- Key documents
- Validation summary reports
- Style and emphasis
- Managing the inspection
- The qualification lifecycle
- How to deal with user requirements
- Qualification documentation
- Critical issues
- Qualification summery report
- Recent general trends
- Highlights from Warning Letters and 483s
- Lessons we must learn
Self Evaluation of Compliance with Annex 11
Review of User Requirements Specifications
A short review of the URS and how to write specifications, as a prelude to a workshop in which delegates will evaluate a real requirements specification.
What is a URS?
Why is it important?
Contents of a URS
Characteristics of good specifications
Based on considerations of the type of application, knowledge of the supplier and how it will be used, delegates will work out the best approach to delivering the benefits of a GxP system
What are the risks associated with delivering the system?
What options do you have to manage the most critical risks?
How can they best be managed?
What are the key issues to monitor to ensure delivery of the project benefits?
Risk Management in Protocol Planning
Based on a real case study, delegates will use the same risk assessment techniques as in Workshop 2 to determine where to focus the qualification of a packaging line.
Risk management applied to a control system
Using FMEA to assess risks to be managed and controlled in validation
Identifying options to mitigate (reduce) the higher risks Using the output in creating the testing protocol
The participants will work on a number of case studies and define the change control activities needed.
Change Control forms
In this workshop examples of deviations will be examined and methods of resolution discussed. The examples are based on real-life protocols.
Test failures found during IQ/OQ
Manage the deviations