US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

Description:

The webinar 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
• 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

Areas Covered in the Webinar :

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.
2. Where Inconsistencies Become a Problem: WHO, ICH, Countries
   • Flexibility in global expectations.
   • Most challenging topics where alignment varies.
3. Key Chapter Reviews
   • ICH GMP organization.
   • Category reviews.
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.
5. GMP Comparisons for APIs
   • Auditing API facilities.
   • Typical audit agenda.
   • ICH Area differences.
6. GMP Comparisons for Finished Products
   • Auditing finished product facilities.
   • Typical audit agenda.
   • ICH Area differences.
7. GMP Comparisons for ……
   • Active Ingredients
   • Finished products [drugs, biologics]
   • Excipient producers
   • Sterile products
   • OTC vs. Prescription
   • Implications for Contract Manufacturers
8. 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.
9. Outsourcing Management…….a Regional Perspective on:
   • Contract manufacturing.
   • Contract packaging.
   • 3 rd Party Contract testing.
10. 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.
11. Conclusions / Wrap-Up

Who Will Benefit:

This Webinar will provide invaluable assistance to all License Holder personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:

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