Topics
- The difference between a nonconformance and nonconformities
- The concepts of sampling when conducting quality audits
- Using standard sampling plans in an audit
- The use of (non-statistical) convenience samples
- An examination of the FDA’s QSIT sampling plans
- Using the binomial distribution to understand audit sampling
Who should Attend
Audit Managers, Quality Managers, Quality Auditors, Lead Quality Auditors, Suppliers to medical device companies and Regulatory Affairs Managers.