Process Validation & Equipment Validation

DAY 1

• Benefits of Process Validation
• European and FDA Regulation and Guidance on process validation
• Validation Regulations interactive quiz New
• Validation Planning - designing master validation plans
• Writing Validation Rationales New
• Case Study - determining what needs to be included in the MVP for a specific manufacturing process New Content
• Validation versus Verification – implementing the GHTF approach
• Exercise on Validation versus Verification
• Requirements Specifications - Case Study writing a URS

DAY 2 

• Application of Risk Analysis to Validation New Updated Content
• Equipment Design Qualification – comparing Specifications to Requirements
• Requirements Tracing – using the RTM to plan qualification testing
• Equipment Qualification
• Incorporating Software Validation into Equipment Validation New
• Process Optimization, Process Capability and Process Control Updated Content
• Case Study writing an equipment IQ Protocol
• Case Study writing an equipment OQ Protocol
• Application of Statistics to Validation New Updated Content
• Statistical Rationale for Samples Sizes New Updated Content

Day 3

• Process Performance Qualification
• Case Study writing a PPQ Protocol New Updated Content
• Product versus Process Validation
• Test Method Validation for physical test methods New Updated Content
• Gauge R&R and the alternatives to Gauge R&R
• Validation Reporting – How to present data and draw conclusions New
• Continued Process Verification
• Maintaining the Validated State New Updated Content
• End of Course Assessment. New

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

Upon completion of this course, participants will be able to;

• Identify the regulatory requirements for process validation,
• Sate the benefits of conducting validation studies,
• Demonstrate an understanding of the key elements of process validation,
• Appreciate European and 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 GHTF regarding verification and validation,
• Design a validation master plan,
• Write requirements for process equipment,
• Assess process and equipment risks,
• Conduct equipment design reviews,
• Write IQ test cases,
• Write OQ test cases,
• Write PPQ test cases,
• Report on Validation testing results,
• Assist in ensuring that the validated state is maintained.

Abbreviations used in this document:

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

• 

  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 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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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.