Process Validation & Equipment Validation Training Course

Process Validation is a key requirement of Medical Device, Pharmaceutical and API regulations. A comprehensive, well thought-out approach to validation is a critical element of any company’s approach to meeting European, US and Worldwide regulatory requirements. This course gives attendees a good grounding in the practices and principles of process validation and expectations of regulatory bodies, such as the US FDA, in relation to process validation.

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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.

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