Process Validation & Equipment Validation With SQT Training

By gemmacreagh - Last update


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Are you looking to develop your career in the Medtech industry? SQT Training are running a virtual training course in Process Validation & Equipment Validation. 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.

  • Duration: 2 training days
  • Course Times: 9.00am – 5.00pm
  • Virtual Training Price: €795
  • Dates: 15th & 16th July

Process Validation & Equipment Validation Training

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?Expand/Collapse

  • 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?Expand/Collapse

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

Find out more about this course, or register your place here.


gemmacreagh

Gemma is a nomadic writer, filmmaker, & journalist.
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