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?
- 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.
