Advanced Equipment Qualification and Process Validation Training

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.

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.

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

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.

Andy Marshall – Andy has extensive experience in validation and quality management roles in contract manufacturing for Active Pharmaceutical Ingredients. He is an expert in pharmaceutical water systems (Purified Water and Water for Injection), acting for clients as subject matter expert during FDA and MHRA inspections. Andy has also developed pharmaceutical quality systems for start-ups and as part of remediation activities.