US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus (Bloomington, MN, United States - October 4-5, 2018)

  • ID: 4450671
  • Conference
  • Location: Bloomington, MN, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: October 4-5, 2018
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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.
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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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  • Robert J. Russell Robert J. Russell,
    President ,
    RJR Consulting, Inc.


    Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

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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:

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

Embassy Suites by Hilton Minneapolis Airport
7901 34th Ave South
Bloomington, MN
55425
United States

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