Process Validation in the US and EU (Workshop, London)

DUBLIN, October 30, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/spmsvz/process) has announced the addition of the "Process Validation in the US and EU (Workshop, London)" conference to their offering.

     (Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

Key topics to include: 

• Science and Risk Based Approach to Process Validation for Pharmaceutical and Biopharmaceutical Products
• Quality Risk Management
• FDA Process Validation Guidance
• EU Process Validation Guideline
• EU Draft Annex 15
• Lifecycle Approach to Process Validationn Process Design
• Equipment and Utility Qualificationn Process Performance Qualification / Process Validationn Continued Process Verification / Ongoing Process Verification
• Continual Improvement and Process Optimisationn Process Improvement
• Implementation Challenges
• Business Benefits

Benefits In Attending: 

• Understand the link from product requirements, to equipment verification and process validation
• Understanding the similarities and difference between process validation expectations in EU and US
• Establish a Process Validation programme
• Understand the link between Quality by Design and Process Validation
• Gain a practical, science and risk based approach to Process Validation including Equipment Verification
• Apply relevant tools for Process Validation, such as Risk Assessments, Design of Experiments and Statistics
• Gain knowledge in Good Engineering Practice (GEP)
• Unscramble the real meaning of buzz words' such as Qualification, Verification, Commissioning, Validation etc.
• Realise significant business benefits from a science and risk based approach

Who Should Attend: 

This seminar will be of particular interest to all those from the Pharmaceutical Industry working in: 

• Development
• Manufacturing
• Engineering
• Quality

Personnel from the Pharmaceutical and Biopharmaceutical Industry including: 

• Process Engineers
• Pharmacists
• Scientists
• Quality Assurance Professionals
• Quality Control Managers
• Late Stage Product and Process Development Engineers,Scientists, Pharmacists
• Technology Scale up and Transfer Managers
• Validation and Qualification Managers
• Validation and Qualification Specialists
• Risk Management Specialists
• Lean Management Specialists
• Operation Managers, Engineers

Key Topics Covered: 

Day One 

09.30 - Welcome and Introduction 

10.00 - The Science and Risk Based Approach to Process Validation 

10.30 - ICH Q8/9/10/11 

11.00 - Coffee 

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 - Tea 

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 Day One 

Day Two 

09.00 - Introduction to Day Two 

09.15 - Quality Risk Management 

09.45 - Exercise 4: Process Validation 

10.45 - Coffee 

11.05 - Continued Process Verification / 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 - Tea Break 

15.45 - Discussion: Implementation Challenges 

16.00 - Case Study: Continued/ Ongoing Process Verification 

16.30 - Feedback and Discussion 

16.45 - End of Seminar 

Speakers 

- Bruce Davis is a professional Engineer with 20 years international experience of projects for Drug Substance and Drug Product manufacturing facilities. He was with AstraZeneca where he led major changes to qualification processes globally as well as leading Quality by Design (QbD) cross-functional workshops for new products. He is past ISPE Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published. 

- Line Lundsberg, PhD is a Scientist with many years of practical experience from the Pharmaceutical Industry. She works as a consultant and serves several global organisations implementing Quality by Design and Science and Risk based Process Validation. She is one of the co-authors of the ISPE Good Practise Guide: Product Realisation using QbD, Concepts and Principles. 

For more information visit http://www.researchandmarkets.com/research/spmsvz/process

Media Contact: Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets