About This Course

This highly participative three-day process validation 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. Learn how the science and risk-based approach to validation can deliver business efficiency, increase reliability, enable robust processes and assure product quality. Doing so can add real value to your business while providing better protection to patients.

Our tutors are internationally recognized experts in the field and can help you efficiently perform equipment qualification and pharmaceutical validation studies that meet the needs of regulators in the U.S. and Europe.

For example, the 2011 FDA Guidance on Process Validation and the 2015 EU Good Manufacturing Practice (GMP) Annex 15 introduced a new approach to equipment/facility/utility qualification and process validation. This course provides a demonstration of the practical application of the science and risk-based approach to qualification and validation that meets these dramatically revised regulations.

We explain how facility/utility/equipment 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. Our course shows you how to efficiently plan, design, execute and document qualification/validation activities 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 facility/utility/equipment qualification and process validation and introduced regulatory expectations
  • How to gain process understanding and how this links to effective process validation
  • The key components expected for effective facility/utility/equipment 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 facility/utility/equipment qualification and process validation:
    • Risk management tools
    • Statistical tools, e.g. process capability, design of experiments (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 a user requirements specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (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, e.g. control charts, process capability, DoE, multi-variate analysis

Change Management

Who Should Attend

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

Course Tutors

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 Quality by Design (QbD), Process Analytical Technologies (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, and was responsible for implementing PAT solutions, QbD and validation projects.

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.