Course "US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
- 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
Who will benefit:
This Seminar 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:
- Quality Assurance
- Senior management
- Project Managers
- Qualified Persons (QPs)
- CMC Personnel
- Packaging Experts
- Business / Commercial functions
Day 1 Schedule
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
Day 2 Schedule
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
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President / CEO , RJR Consulting, Inc.
Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.
Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
Location: Minneapolis, MN Hotel: Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425