This event is cancelled or expired.
Jun
2017
Effective and Efficient Process Validation 'The Science and Risk-Based Approach’
United Kingdom, Manchester
Course Overview:
This highly participative three-day training course is designed to ensure that you understand the latest EU and FDA requirements for the design, execution, assessment and reporting of process validation studies. Our tutors are internationally recognized experts in the field and they will help you to be able to perform process validation studies which meet the needs of the regulators in an efficient manner that will add real value to your business!
About This Course:
Learn how the science- and risk-based approach to validation can deliver business efficiency, enable robust processes and assure product quality
European and American expectations for process validation and equipment qualification have changed dramatically in recent years. The recent regulatory guidance (FDA Process Validation Guidance 2011, EU CHMP Guidance on Process Validation in 2014 and 2016 and EU GMP Annex 15, 2015) has spearheaded a sharper and more focused approach to validation.
This course provides a demonstration of the practical application of this science- and risk-based approach to both process validation and qualification of equipment/facilities/utilities. It will include an in-depth explanation of the three stages from initial development through to sustaining quality over the product lifecycle. The course will use practical case studies and provide supporting detail of important tools such as application of statistics, quality risk management and Process Analytical Technologies (PAT).
You will obtain an insight into the requirements for design, execution, assessment and reporting of process validation.
We will explain :
- The link from process validation to patient need
- US and EU regulatory requirements
- Use of tools such as risk management and statistical data analysis
- How to plan, design and execute qualification of facilities, utilities, equipment and systems
You will learn how to apply these concepts to new and existing processes. We will show how use of these tools, applied to your products and processes will add real value to your business and provide better products for patients.
Key learning objectives :
- To understand the latest regulatory expectations for process validation for manufacturers and during development
- To understand how product and process understanding (e.g. from development studies and manufacturing experience) are a fundamental link to effective process validation
- To apply ICH documents Q8, Q9, Q10, Q11 and recognize the importance of draft Q12
- To understand the key components expected for process validation
- Product and process understanding
- Qualification of facilities, equipment, utilities and systems
- Assessing how many batches
- Assuring control over the product lifecycle
- To understand the tools and techniques that can help streamline the process validation process
- Risk management tools, statistical tools; process capability, Design of Experiments (DoE)
Registration link :
- NSF Online registration : Link
NSF contact :
- Phone : +44 (0) 1751 432 999
- email : pharmacourses@nsf.org
- visit : www.nsf.org/info/pharma-training
Note :
- All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Course Outline:
The Concept of Process Validation
Current Regulatory Expectations
- The impact of ICH Q8, 9, 10, 11 and draft Q12
- The FDA 2011 and EU 2014 and 2016 guidance on process validation and the 2015 EU GMP Annex 15
- The practical expectations for a three stage approach involving process design, process qualification and ongoing/continued process verification
How to Gain Process Understanding (FDA Stage 1)
- Identification of critical quality attributes (CQAs) and critical process parameters (CPPs)
- Developing and applying a control strategy for process validation
Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1)
- Writing and documenting URS, DQ, IQ, OQ, PQ
Process Validation/Process Performance Qualification (PV/PPQ) (FDA Stage 2.2)
- The importance and content of protocols
- Setting of acceptance criteria
- When to begin to commercialize (how many batches?)
- Understanding residual risk
Continued/Ongoing Process Verification (FDA Stage 3)
- How to maintain a state of control over the product lifecycle
- Implications of changes on supply chain
Tools that Enable Effective and Efficient Process Validation
- Quality risk management and risk register
- Statistical tools; control charts, process capability, DoE, multi-variate analysis
Change Management
New for 2017 – We provide an optional post-course assessment that verifies proficiency of all course attendees
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Line Lundsberg
Consultant
NSF Health Sciences Pharma Biotech
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Bruce Davis
Consultant
NSF Health Sciences Pharma Biotech
Resume
Line is an expert in QbD, PAT and validation. She is chairperson of the ISPE PQLI Control Strategy Team focusing on implementing control strategies in real life. She has previously worked at Lundbeck and Novo Nordisk, being responsible for implementing PAT solutions, QbD and validation projects.
Bruce Davis has over 20 years’ experience in the pharmaceutical industry. He is an engineer by profession and a member of the Institution of Civil Engineers.
His recognized areas of expertise include :
- Quality by design training
- Pharmaceutical facilities
- Qualification
- Business/engineering studies
- Working with universities
- Communication of technical matters in an understandable way
Before joining NSF Health Sciences Pharma Biotech, Mr. Davis worked with AstraZeneca in a number of roles including responsibility for new drug product and drug substance manufacturing and development facilities internationally and for oral solid dosage, aseptic, liquids, inhalation and packaging. He has a wide international experience and has been responsible for plants and leading studies for facilities in Europe, the Americas and Asia. Bruce was also responsible for leading a change process to modernize the company approach to equipment qualification and for facilitating cross functional teams in quality by design.
He is a past chair of ISPE’s International Board of Directors and is secretary to the ASTM E55 Committee that develops pharmaceutical standards.