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Process Validation & Equipment Validation

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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... Read More

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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What's covered?

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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

Who should participate?

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  • 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.

What will I learn?

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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

Who are the tutors?

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How do we train and support you?

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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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SnapshotSnapshot

Duration
2 training days
Course Times

9:00am to 4:30pm

Price
Public Virtual Training: €795

(includes course documentation).

Delivery Mode
This programme is available In-House, and via Public Virtual Training
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Process Validation & Equipment Validation

Duration: 2 daysPublic Price: €895
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Process Validation & Equipment Validation

Duration: 2 daysVirtual Training Price: €795
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