2-Day Seminar: Process Validation with Qualification (London, United Kingdom - October 16-17, 2019) - ResearchAndMarkets.com

January 28, 2019

DUBLIN--(BUSINESS WIRE)--Jan 28, 2019--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.


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

View source version on businesswire.com:https://www.businesswire.com/news/home/20190128005315/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Pharmaceutical Manufacturing



SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 01/28/2019 07:30 AM/DISC: 01/28/2019 07:30 AM


Update hourly