Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles
- How the concept of Process Validation is about to change
- Ongoing changes in the Quality Management philosophy
- Comparison of Annex 15 revision with FDA Process Validation Guidance
- Real-life examples
Ongoing Process Verification – View of an EU Inspector
- EU process validation lifecycle approach (overview)
- EU GMP requirements on EU-OPV
- Authorities expectations regarding PQR
- Interaction and linking with EU-PQR
- Comparison of EU and US requirements to maintain status of control
Case Study: From Control Strategy to Statistical Process Control
- Introduction in biopharmaceutical processes
- Process development and definition of parameters
- Parameters and control
- Control Strategy
- Process Performance Validation Approach
- Statistical Process Control
Case Study: Large Molecules: Process Validation and Statistical Trending in Biopharmaceutical Manufacturing
- Basic Statistics
- Content of CPV protocol/report
- Trending program and related procedures
- Evaluation of Trends and CAPAs
- Link to APR/PQR
Parallels between Medical Device and Drug Process Validation
- Leveraging experience
- Quality System similarities
- Standard Approaches – foundation for implementation
Recent trends in FDA inspections, observations and warning letters
- Examples of expectations and enforcement
- Regulatory enforcement trends related to observations and Warning Letters
SPC as tool for Continued Process Verification
- Continued Process Verification: Requirements
- Case Study Sanofi-Aventis
Case Study: How to implement CPV of a legacy process
- Challenges
- Experiences
- Lessons learnt
The bridge between the traditional and a new life cycle validation approach - the way to continuous process verification
- Hybrid Validation approach as a interim solution
- Technology upgrade
- Case study: OPV program for small business
- A concept for the definition of the critical parameters/attributes and the documentation strategy in consideration of the data integrity
Workshop Continued Process Verification – Process Data Evaluation and Conclusions
- The delegates analyse in small groups process data regarding the validity of a legacy process.
The future role of PAT, industrial IT and automation in continued process verification: Implementing a control strategy
- Control strategy and implications for automation solutions
- Bridging islands of information systems in manufacturing
- From data to information to knowledge: getting gold out of data
- Continued process verification: monitoring challenges
- Window to the Quality: The future role of automation and IT systems in manufacturing?