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.
Benefits of attending:
This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:
Personnel from the pharmaceutical and biopharmaceutical industry with the following background:
The Science and Risk-Based Approach to Process Validation
ICH Q8/9/10/11
Introduction to the FDA Process Validation Guidance
Introduction to the EU Process Validation Guideline and Draft Annex 15
Discussion
Exercise 1: Guidelines
Process Design: FDA Stage 1/EU Pharmaceutical Development
Exercise 2: Process Design
Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15
Exercise 3: Equipment Qualification
Feedback and Discussion
Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches
Introduction to Day Two
Quality Risk Management
Exercise 4: Process Validation
Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15
Exercise 5: Ongoing Process Verification
Continual Improvement and Process Optimisation
Exercise 6: Continual Improvement
Feedback and Discussion
Case Study: Process Improvement
Discussion: Implementation Challenges
Case Study: Continued/Ongoing Process Verification
Feedback and Discussion
Bruce Davis (6-7 Mar 2019)
Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.
6-7 Mar 2019 | |||
6-7 Mar 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
16-17 Oct 2019 | |||
16-17 Oct 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |