Auditing QC and Contract Laboratories for GMP Compliance 2015

Key Topics

• FDA and international requirements for laboratory audits
• Why are internal audits important
• Developing an SOP for `FDA Inspection Like` audits
• FDA and EMA inspections as models for laboratory audits
• The audit team: members, tasks, responsibilities
• Developing an audit schedule
• Looking at the right documentation
• Most critical audit areas based on risk assessment
• Audit items along the sample and data workflow from sampling to record archiving
• Auditing the laboratory quality system
• The importance of the exit meeting
• Assessment through laboratory walkthrough
• Follow-up with corrective and preventive actions: Going through six case studies
• Writing the audit report

Who should Attend

• Lab supervisors and managers
• GMP auditors – internal and external
• QA managers and personnel
• Analysts and other laboratory staff
• Consultants
• Training departments