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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 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 Managing the Audit.......the Importance of the QA Audit Generalist Importance of SMEs [subject matter experts] Processes & timelines Acknowledging previous Healthcare Authority Audits.......when is it possible? Examples of unique experiences encountered during audits

Course Audience:
  • Manufacturing
  • Quality Assurance
  • Senior management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory
  • CMC Personnel
  • Packaging Experts
  • Business / Commercial functions
  • Consultants

Day 1 Schedule Lecture 1: U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading Current efforts to further harmonize GMP requirements Future expectation & likely progress Lecture 2: Where Inconsistencies Become a Problem: WHO, ICH, Countries Flexibility in global expectations Most challenging topics where alignment varies Lecture 3: Key Chapter Reviews ICH GMP organization Category reviews Lecture 4: Compliance with ICH Guidelines for GMPs Understanding and Insight into Healthcare Authority expectations How GMP requirements / inspections can differ with a single ICH Standard How regulators (from 3 regions) will assess / enforce compliance with Q7 Lecture 5: GMP Comparisons for APIs Auditing API facilities Typical audit agenda ICH Area differences Day 2 Schedule Lecture 1: GMP Comparisons for Finished Products Auditing finished product facilities Typical audit agenda ICH Area differences Lecture 2: GMP Comparisons for ....... Active Ingredients Finished products [drugs, biologics] Excipient producers Sterile products OTC vs. Prescription Implications for Contract Manufacturers Lecture 3: Differences on Area GMP Inspections Differences on how GMP inspections are conducted Areas of GMP inspection focus by area Modifying your self-inspection systems to customized area concerns Lecture 4: Outsourcing Management......a Regional Perspective on: Contract manufacturing Contract packaging 3rd Party Contract testing Lecture 5: Auditing Your Facilities for Global Considerations Importance of pre-audits to regional GMP focus How to focus your internal audits to a US, EU and Japan compliance system Lecture 6: Conclusions / Wrap-Up

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