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.
