GlobalCompliancePanel

- US, EU and Japan Practical ICH Area Differences, Healthcare Authority Inspection Focus

Description: This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. The seminar will discuss in detail the: • Types of inspections done by US FDA, EMA and PMDA • Typical Audit Agenda that can be expected by each Authority • Scope of Audits.........how many auditors, how many days • When audits will likely occur • The expectation differences between inspections of API and Finished Product facilities • What areas of GMP become a focus by region • Typical audit observations by region [by Healthcare Authority] • Getting ready / preparation / self-inspection / mock audits