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
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.
| 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% |
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“Very informative and engaging. Also valuable the additional inputs with regards to regulatory expectations which may not be apparent just from reading guidances. ”
Ming Tong, Principal Protein Scientist, Piramal Pharma Solutions
“Very good”
Adele Millar, Product Support Officer, Porton Biopharma LTD
“Excellent, will recommend other attend or arrange In-house course ”
Ian Lafferty, VP Technical Services, Juniper Pharma Services
“It is a really interesting course with a lot of valuable information and the speaker has a very good way of presenting the info in effective way ”
Nancy Almashni, ,
“Well defined and appropriate discussions governed by industry experts. Great presentation and supporting documents ”
Andrew Betts, Site Quality Leader, Purolite Ltd
“Content very good with lots of examples and exercises to test understanding ”
Lorraine Wallace, QA Associate Manager, Fujifilm Diosynth Biotechnologies
“The course had aspects that were useful - but the overall content was not really applicable to my role. This was obvious within the first five minutes of the Day 1 when we reviewed objectives. As stated above, maybe this was a misinterpretation of course content ”
Anna Owens, Quality Assurance Manager, Associates of Cape Cod International Inc
“Content appropriated and excellent speakers”
Marta Lopez Garcia, Senior Technical Manager, Bayer Consumer Care AG