US, EU, Japan GMP Requirements
Instructor: Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic 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. Why you should Attend:
- 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
- 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
- Where Inconsistencies Become a Problem: WHO, ICH, Countries
- Flexibility in global expectations
- Most challenging topics where alignment varies
- Key Chapter Reviews
- ICH GMP organization
- Category reviews
- 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
- GMP Comparisons for APIs
- Auditing API facilities
- Typical audit agenda
- ICH Area differences
- GMP Comparisons for Finished Products
- Auditing finished product facilities
- Typical audit agenda
- ICH Area differences
- GMP Comparisons for
- Active Ingredients
- Finished products [drugs, biologics]
- Excipient producers
- Sterile products
- OTC vs. Prescription
- Implications for Contract Manufacturers
- 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
- Outsourcing Management a Regional Perspective on:
- Contract manufacturing
- Contract packaging
- 3rd Party Contract testing
- 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
- Conclusions / Wrap-Up
- Manufacturing
- Quality Assurance
- Senior Management
- Project Managers
- Qualified Persons (QPs)
- Regulatory
- CMC Personnel
- Packaging Experts
- Business / Commercial functions
- Consultants
His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products. For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries. He holds a BS / MS in Chemistry."