- How the concept of Process Validation is about to change
- Ongoing changes in the Quality Management philosophy
- Real-life examples
The current EU Approach on Process Validation
- Process validation in EU guidelines
- What has changed?
- Revision of Chapter 1 EU GMP Guide
- EMA´s Guidance Process Validation
- Annex 15 revision
- Excursion QbD
- Excursion Legacy Products
- The future of process validation
Background and Environment of Process Validation – Industry view
- Process Validation in guidelines – history
- The FDA Process Validation Guidance –an overview
- European perspective
- Annex 15 revision
Case Study Process Validation
- Role of SOP in the company QM System
- How to deal with the established 3 batch approach?
- Key aspects (Preconditions, Stages 1-3, Review)
- Further deliverables from the data and link to other company SOPs
Basics on Statistics
- An overview about statistical aspects
- What statistics do you need for modern Process Validation?
- Quality by Design and how it is an enabler for Process Design
Systems and Tools for gaining Process Understanding and establishing the appropriate Control Strategy (I)
- Quality Risk Management
- Process Analytical Technology
- Design of Experiments (including a practical factorial design for establishing the design space or the operating ranges for the process)
- How the process design is reflected in the control strategy
- Applying control strategy for stage 2, process qualification and process validation
Performance Qualification Approach
- Design & qualification of facility, utilities & equipment
- Performance qualification approach
- Performance qualification protocol
- Documenting the quality baseline
Continued/Ongoing Process Verification
- Process mapping & critical process variables
- Process data collection and collation
- Trend analysis & Statistical Process Control
- Deviation management & CAPA
- Change management
- Management’s role in Process Validation
The delegates examine a process flow diagram and generate an Ishikawa diagram to identify critical elements.
The delegates make a statistical evaluation of validation data (e.g. trend analysis, Cpk).
Continued/Ongoing Process Verification Workshop
The delegates make a High Level Risk Assessment to analyze where they are going to focus in process verification.