Equipment Qualification & Process Validation: The Science- and Risk-Based Appraoch

NSF International, Pharmaceutical Services
Course summary
3 days
2,110 GBP excl. VAT

Course description

Equipment Qualification & Process Validation: The Science-and Risk-Based Approach

This highly participative three-day process validation and equipment qualification 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!

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - 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.

Outcome / Qualification etc.

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.

Training Course Content

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


Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Samantha Mannion, Thornton & Ross, UK
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.
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