Two day Course: Process Validation with Qualification (London, United Kingdom – March 6th-7th, 2018)

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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 in attending:

  • Know the scope of the FDA and EU validation guidelines
  • Establish a 3 stage, science-and-risk-based, lifecycle process validation programme
  • Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
  • Understand how Quality by Design supports process validation
  • Link product requirements, to equipment verification to commercial scale process validation
  • Gain knowledge in qualification including Good Engineering Practice (GEP)
  • Apply tools such as Quality Risk Management, Design of Experiments and Statistics
  • Unscramble the real meaning of buzz words' such as qualification, verification, commissioning, calidation etc.
  • Realise significant business benefits from taking 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 with the following background:

  • 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
  • Operations managers and engineers


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

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]  

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

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

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SOURCE Research and Markets

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Maria Burns

Maria Burns

Maria is a Viral News Editor who graduated from the University Of California. She likes social media trends, being semi-healthy, Buffalo Wild Wings and vodka with lime. When she isn’t writing, Maria loves to travel. She last went to Thailand to play with elephants and is planning a trip to Bali.
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