Laboratory Inspections – Be Prepared, Be Validated and Avoid Observations 2015

Key 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.