DUBLIN--(BUSINESS WIRE)--The "Process Validation with Qualification" conference has been added to ResearchAndMarkets.com's offering.
Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment.
The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.
Agenda
Programme Day One
- 09.00 Registration and coffee
- 09.30 Welcome and Introduction
- 10.00 The Science and Risk-Based Approach to Process Validation
- 10.30 ICH Q8/9/10/11
- 11.20 Introduction to the FDA Process Validation Guidance
- 11.50 Introduction to the EU Process Validation Guideline and Draft Annex 15
- 12.20 Discussion
- 12.30 Lunch
- 13.30 Exercise 1: Guidelines
- 13.50 Process Design: FDA Stage 1/EU Pharmaceutical Development
- 14.20 Exercise 2: Process Design
- 14.50 Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15
- 15.20 Refreshments
- 15.35 Exercise 3: Equipment Qualification
- 16.10 Feedback and Discussion
- 16.25 Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches
- 17.00 End of Day One
Programme Day Two
- 09.00 Introduction to Day Two
- 09.15 Quality Risk Management
- 09.45 Exercise 4: Process Validation
- 10.45 Refreshments
- 11.05 Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15
- 11.35 Exercise 5: Ongoing Process Verification
- 12.05 Continual Improvement and Process Optimisation
- 12.30 Lunch
- 13.30 Exercise 6: Continual Improvement
- 14.30 Feedback and Discussion
- 15.00 Case Study: Process Improvement
- 15.30 Refreshments
- 15.45 Discussion: Implementation Challenges
- 16.00 Case Study: Continued/Ongoing Process Verification
- 16.30 Feedback and Discussion
- 16.45 End of Seminar
For more information about this conference visit https://www.researchandmarkets.com/research/kzrrsx/2day_seminar?w=4
