Topics
- How to recognize when you are using software in production or the quality system
- The pitfalls of using Excel without a good regulatory plan
- The FDA’s requirements and expectation for production and quality system software
- The use of Excel tools to help ensure spreadsheets are built correctly
- The requirements of Part 11 for electronic records and the current guidance document
- The reason for Part 11 and some of the implications
Who should Attend
Production and Process Engineers, Quality Engineers, Design Engineers, Manufacturing Engineers, Purchasing Agents, Purchasing Managers, Quality Supervisors, Supplier Quality Engineers, Quality Managers, Quality Inspectors, Quality Auditors and Quality Audit Managers.
