Method Validation Auditing and Assurance
3 days|Delivered on request
This programme is written from the assurance side. Delegates learn to test whether document control and laboratory design are working as claimed, and how to evidence the conclusion. Assurance work is under scrutiny because method validation is frequently treated as paperwork rather than as evidence. Delegates leave able to work confidently with quality management systems, reagent management and supplier qualification in their own organisation.
What delegates leave able to do
- Make a decision about quality management systems without waiting for a specialist, measured against ISO 9001
- Review reagent management and say plainly whether it is working
- Improve supplier qualification within their own organisation
- Put non-conformance management on a footing they can defend to a reviewer
What the course covers
- Document control
- Laboratory design
- Quality management systems
- Reagent management
- Supplier qualification
- Non-conformance management
- Corrective and preventive action
Who should attend
- laboratory supervisors
- quality managers
- technical signatories
- analytical chemists
- quality assurance officers
