How to Host Regulatory Audits (FDA, EU and Health Canada) 2014

Topics

• What to expect during the opening meeting and how to control the audit to your advantage
• Review the items that need to be in place prior to an audit
• Learn typical audit techniques by investigators and how best to handle them
• Practices to implement during the audit and those that need to be avoided
• Learn what your responses should include prior to submitting to the agency for review

Who should Attend

• Manufacturing
• QA/QC personnel
• Validation
• Engineering
• Management
• Regulatory