Auditing API Facilities 2016

Topics

• What to review
• Preparing to perform an audit
• Proper communication to the audited firm or location
• What to learn
• Where do you look?
• How much time do you need?
• What are the systems you need to examine
• What do you look at or look for?
• Use the ICH Q7 Guidance as a guide
• What are the Red Flags to look for during an audit?
• Closing the audit
• Checklist or no checklist?
• Next Steps following the audit

Who should Attend

• Quality Control and Quality Control personnel
• Firms that manufacture or analyze API and firms that purchase API for their drug product
• Inspectors and auditors
• Engineering and Production Management
• Distribution personnel
• Purchasing and materials management personnel
• Regulatory Affairs personnel responsible for filing DMF, NDA, ANDA and another FDA related filings and registrations
• R & D personnel responsible for methods and procedures that will be used by API functions