Process Validation & Equipment Validation Training Course

Expand All

Our fully interactive Process and Equipment Validation course provides attendees with the knowledge and skills they need to comply European, US and Worldwide validation requirements. The course is fully tutor-led and focuses on the practical implementation of validation requirements, providing attendees with a well-thought-out approach and real-world implementation methodologies to help achieve compliance and assure product quality and consistency. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.

For abbreviations used in this document, see end of document.

Collapse

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

Gerry Burke

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

Read More
John Lafferty

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

Read More
Kevina O’Donoghue

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

Read More

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.

Collapse All

Download brochure

Snapshot

Course Code

LS034

Duration

3 training days

Public Price

Virtual Training: £870

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

stdClass Object
(
    [primary_category] => Validation
    [primary_slug] => validation
    [categories_slugs] => Array
        (
            [0] => validation
        )

    [parent_categories_slugs] => Array
        (
            [0] => life-sciences
        )

)

News & Updates

IVD Manufacturers counting down to compliance and the new EU Regulations

IVD Manufacturers: Will you be Compliant with the new EU Regulation 2017/746 when it comes into effect on IVDR by May 2022? Updated insights from our expert Tut...