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2-Day Course: Process Validation with Qualification (London, United Kingdom - March 6-7, 2019) -

The "Process Validation with Qualification" conference has been added to's offering.

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.


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

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Last Updated: 22-Jan-2019