Process Validation & Equipment Validation

DAY 1

• Introduction
• Business Benefits of Process Validation
• Validation Regulatory Requirements & Guidelines
• Validation Master Plans
• Case study (Determining what needs to be included in the VMP for a specific manufacturing process)
• Validation versus Verification
• Exercise on validation versus verification
• Statistical Methods & Tools for Validation
• The application of Risk Analysis to Validation
• Equipment Qualification

DAY 2 

• Requirements Specification
• Case Study Preparation of URS, FRS and FDS documentation
• IQ, OQ and PQ
• Case Study Preparation of Validation Protocols
• Design Qualification and requirements tracing
• Product & Process Validation
• Continued Process Verification
• Maintaining the Validated State
• Test Method Validation for physical test methods

• Personnel in the Medical Device, Pharmaceutical and API sectors who are engaged in validation activities.
• QA & regulatory staff involved in auditing validation protocols and reports.
• Senior Management who need to allocate validation resources & review & approve validation programmes.
• Members of Engineers Ireland who attend this course may claim for CPD hours from Engineers Ireland.

Participants achieve the following learning outcomes from the programme;

• Recognise the regulatory requirements for process validation
• Appreciate the benefits of conducting validation studies.
• Demonstrate an understanding of the key elements of process validation
• Appreciate European & FDA Guidance publications on process validation
• Determine where to use process capability and other statistical methods during validation studies
• Demonstrate an understanding of the approach adopted by the Global Harmonisation Task Force regarding verification and validation
• Design a validation master plan, validation protocols & reports
• Demonstrate an ability to draft equipment requirements
• Demonstrate an ability to draft validation test cases
• Describe the main requirements for maintaining a state of validation

• 

  Carmel McCrea Kelly

  Carmel McCrea Kelly, BSc in Quality Management & Technology...

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• 

  Gerry Burke

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

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• 

  John Lafferty

  John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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• 

  Kevina O’Donoghue

  Kevina O’Donoghue is a PhD graduate of the National Universit...

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In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Where appropriate, course exercises can be carried out using procedures, data etc from your organisation.

Course Manual
Delegates will receive a very comprehensive course manual.