Course Overview

  • “I have a better understanding of the vast subject that validation is. I hope that I get backing to implement some of the guidance given.” Samantha Mannion / Thornton & Ross, UK
  • “Tutors were very knowledgeable, great teachers and used real life experiences to aid explanations.” Helen O’Shea / Roche Products, UK
  • “Good overview of the entire validation process.”Angela Borso / Celgene International Sàrl, Switzerland

This highly participative three-day training course is designed to ensure that you understand the current EU and FDA requirements for the design, execution, assessment and reporting of equipment qualification and process validation studies. Our tutors are internationally recognized experts in the field and they will help you to be able to perform qualification and 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

Join us on this course to ensure that you understand the current requirements for the design, execution, assessment and reporting of qualification and validation studies, and learn how they can bring added value through increased process reliability and product quality.

European and American expectations for equipment/facility/utility qualification and process validation have changed dramatically in recent years. The 2011 FDA Guidance on Process Validation and the 2015 EU GMP Annex 15 have introduced a new approach to equipment/facility/utility qualification and process validation. This course provides a demonstration of the practical application of this science and risk-based approach to qualification and validation.

We will explain how equipment/facility/utility qualification and process validation must link to patients’ needs and regulatory requirements, using tools such as risk management, statistical data analysis and change management to efficiently accomplish this. We will explain how to plan, design, execute and document qualification and validation activities to create an effective and efficient process that can add real value to your business and provide better protection to patients.

You will also learn how to apply these concepts to new and existing processes with beneficial results.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The modern concept of equipment/facility/utility qualification and process validation and recently introduced regulatory expectations
  • How to gain process understanding and how this links to effective process validation
  • The key components expected for effective equipment/facility/utility qualification and process validation
    • Facility design and qualification of equipment and utilities
    • Process performance qualification
    • Change management
  • The tools and techniques that can increase the efficiency and effectiveness of equipment/facility/utility qualification and process validation
    • Risk management tools
    • Statistical tools; process capability, DoE, etc.

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, equipment and 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 Validation

  • Quality risk management and risk register
  • Statistical tools; control charts, process capability, DoE, multi-variate analysis

Change Management

We provide an optional post-course assessment that verifies proficiency of all course attendees.

Who Should Attend

This course is ideal for technical and managerial personnel responsible for equipment/facility/utility qualification and process validation, and quality assurance personnel, in particular Qualified Persons. 

Course Tutors

Course tutors will be:

Bruce Davis

Bruce is an engineer with expertise in validation and Quality by Design (QbD). He previously worked at AstraZeneca, where his responsibilities included leading major engineering projects globally, facilitating cross-functional QbD workshops for new products, and leading an international change process for qualification. He is a past chair of ISPE and for ISPE’s Product Quality Lifecycle Initiative (PQLI).

Line Lundsberg

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.

Course Fees

Course cost (excluding VAT)  £2,060.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities – contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.

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