Process Validation & Equipment Validation

Through interactive case studies and group exercises, this course explores each phase of the validation process, from initial planning through to ongoing compliance. Using the V Model, the modules are designed to ensure learners build step-by-step proficiency in applying validation principles in line with global regulatory requirements. 

Day 1: 

• Benefits of process validation 
• EU and FDA validation regulations and guidance 
• Validation planning and MVP design 
• Validation vs. Verification (GHTF approach) 
• Requirements Specifications (URS case study) 

Day 2: 

• Risk analysis application 
• Equipment Design Qualification 
• Requirement Tracing and RTM 
• Equipment Qualification (IQ/OQ) 
• Process control and capability 
• Statistical rationale for sample sizes 

Day 3: 

• Process Performance Qualification (PPQ) 
• Test method validation (including Gauge R&R) 
• Continued Process Verification 
• Maintaining the validated state 

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises.  If required, content may be tailored to reflect your organisation’s specific processes, risk profile, and regulatory setting. 

This course is intended for anyone involved in the planning, execution, review or approval of process validations required to meet US or EU regulations, or anyone involved in the specification of process or test equipment for use in the life sciences industry. 

The training is particularly beneficial for those involved in: 

• Validation, Process and Equipment Engineering 
• Production, Operations and Technical Services 
• Quality Assurance and Regulatory Compliance 
• Senior Management responsible for oversight, sign-off, or resource planning 
• Members of Engineers Ireland seeking to claim CPD hours 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of the training, learners will be able to: 

• Identify EU, FDA and international regulatory requirements for process validation 
• Explain the key benefits and objectives of process validation activities 
• Develop a validation master plan 
• Write clear and structured User Requirements Specifications (URS) 
• Conduct equipment and process risk assessments using standard tools 
• Apply statistical approaches to sample size determination and process capability 
• Prepare and execute IQ, OQ and PPQ protocols aligned to regulatory expectations 
• Trace requirements through the validation lifecycle using tools like the RTM 
• Validate physical test methods, including Gauge R&R and suitable alternatives 
• Sustain the validated state through robust continued process verification  

These outcomes ensure that learners return with the practical skills and knowledge necessary to validate reliable processes and meet regulatory requirements. 

This course is delivered by highly experienced tutors with regulatory and operational expertise in validation. Each tutor brings real industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from expert-led training and comprehensive feedback throughout the course. 

• 

  Gerry Burke

  Gerry is a self-motivated medical industry professional with kn...

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• 

  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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• 

  Kevina O’Donoghue

  Kevina takes great pride in the training she delivers. She unde...

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To consolidate learning and reinforce key concepts, learners complete a post-course assessment. The assessment; 

• Checks understanding of the course content and practical scenarios 
• Assesses real-world understanding and application 
• Is completed within one week of course completion 

Successful learners receive: 

A Certificate of Achievement, in addition to their Certificate of Attendance 

Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs 

• Pre-training consultation for in-company courses to tailor content to organisational needs 
• Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation. 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Live training is available virtually or delivered onsite to suit the needs of the team 
• Real-time support from expert tutors 

Class sizes are generally limited to 12-15 participants to support personalized learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• Software Validation 
• Risk Management for Medical Devices (ISO 14971) 
• Mastering CAPA in the Medical Device / Pharmaceutical Industry 
• Technical Writing Skills 

Abbreviations

• CAPA: Corrective and Preventive Action 
• CPD: Continuous Professional Development 
• GHTF: Global Harmonisation Task Force 
• IQ: Installation Qualification 
• MVP: Master Validation Plan 
• OQ: Operational Qualification 
• PPQ: Process Performance Qualification 
• R&R: Repeatability and Reproducibility 
• URS: User Requirements Specification