Advanced Equipment Qualification and Process Validation

This highly participative 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 US 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.

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 such as control charts, process capability, DoE, multivariate analysis
• Change management

Course Tutor

Tamryn Hassel – Tamryn is an experienced, compliance-driven quality professional and MBA with over 16 years of progressive experience and a proven record of significant and successful contributions in Pharmaceutical Management Systems. She was part of a global team leading investigations on the COVID vaccine supply chain and was responsible for the setup of a QC Microbiology site of excellence.