- Location: Acist Skillnet, Grand View House, Ennistymon Road, Lahinch, Co. Clare.
- Duration: 1 Day
Course details
This is a foundation course in process validation for medical technology industry.
Course Content:
Understand the context of Process Validation within the Quality Management System. Be familiar with the definitions and terminology of validation. Know about the lifecycle of validation. Appreciate the quality regulations pertaining to the Medical Device industry. Be familiar with the documents containing quality regulations. Consider what happens if validation goes wrong. Appreciate their own role in the product they validate, make or support. Understand the role of process control in
maintaining a validated state. Consider the difference between validation and verification. Appreciate the documents and records required to support process validation. Understand basic concepts of supporting regulations such as Part 11 compliance.
Learning Outcomes:
- Understand the context of Process Validation within the Quality Management System
- Be familiar with the definitions and terminology of validation
- Know about the lifecycle of validation.
- Appreciate the quality regulations pertaining to the Medical Device industry
- Be familiar with the documents containing quality regulations
Course Location
About ACIST Skillnet
ACIST Skillnet provides subsidised training to private sector companies based mainly but not limited to the Mid-Theyst Region of Ireland. This Skillnets network was founded in 2006 and has trained over 5000 people in a range of disciplines but particularly focussing on the Tourism sector. They provide off the shelf courses to companies and also develop training specifically designed for business needs. Training is provided for all levels of employees.
ACIST Skillnet is funded by member companies and the Training Networks Programme, an initiative of Skillnets Ltd. Funded from the National Training Fund through the Department of Education, Training and Skills. Skillnets funds and facilitates training through over 80 networks of private sector companies, in a range of sectors and regions.
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