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Process Validation with Qualification (London, United Kingdom - March 3-4, 2020)

  • ID: 4846468
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: March 3-4, 2020
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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

Course Overview

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:

  • Know the scope of the FDA and EU validation guidelines
  • Establish a three-stage, science and risk-based, lifecycle process validation programme
  • Clarify similarities and differences between EU and US expectations
  • Understand how Quality by Design supports process validation
  • Realise significant business benefits from taking a science and risk-based approach
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Programme - Day one

  • 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

Programme - Day Two

  • 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
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  • Bruce Davis Mr Bruce Davis,
    Associate ,
    NSF Healthsciences


    Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences.

    He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations.

    He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU.

    He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices.

    He played a leadership role to set up De Montfort University’s MSc distance learning course in QbD.
    He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.

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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
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ADDRESS

Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom


DIRECTIONS

The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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