Topics
- Reduce costs, anxiety and observations of audits
- Be prepared for internal and external audits
- How auditors think and what they are looking for
- Know what to say and show, and what Not to say and show
- Best practices for instrument qualification, test method validation and data system validation to avoid observations ("483s")
- Write audit observations, responses, remediation plans and corrective actions
- Have the answers to the auditors` questions
- When to do what to meet audit requirements economically
Who should Attend
Quality Assurance, Laboratory Managers, Laboratory Analysts/Chemists, Quality Control, Regulatory Compliance, Analytical Development, Contract Research Organizations, Contract Laboratories, Auditors and Contract Manufacturing Organizations.