Process Validation & Equipment Validation

By Gemma Creagh - Last update

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Do you want to further your career in the MedTech industry? SQT Training is offering specialist training in Process Validation & Equipment Validation 14th – 15th May 2019.

  • Duration: 2 training days
  • Course Times: 9.00am – 5.00pm
  • Price: €895(includes course documentation, lunch and refreshments).
  • Delivery Mode: this programme is available In-House and on certain Public dates

Process Validation & Equipment Validation Training

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.

Who Should Attend?

  • 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?

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

If you’re thinking about booking on, or need more information, visit the course page.

Gemma Creagh

Gemma is a nomadic writer, filmmaker, & journalist. She was born in Cork, lives in Dublin, and studied in Belfast & Galway, where she graduated from NUIG’s Writing MA. She has penned articles for national publications and is the editorial assistant for Film Ireland Magazine. Gemma was the writer and co-producer of the five-part comedy ‘Rental Boys’ for RTÉ’s Storyland. Her short films have screened at festivals around the world.
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