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

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Mon, May 22, 2017
Length
60 minutes
Product Description

Area Differences in ICH GMP Requirements for US, EU and Japan


Join this webinar by expert speaker Robert Russell who will provide you with an opportunity to understand the requirements of ICH GMP comprehensively. You will learn about the nuances and differences between the three main triumvirate regions of ICH—US, EU and Japan.

The session will cover the key areas of establishment of ICH, the objectives and goals, expectations of the healthcare authorities involved, and the practical differences which you would experience in inspection of a GMP facility by FDA, which is PMDA’s EU competent authority.

Session Agenda:

  • U.S., EU and Japan GMPs - status of harmonization and where we're heading
    • Current efforts to further harmonize GMP requirements
    • Future expectations and 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
    • Excipients
    • Sterile products
    • Biologics
    • Clinical packaging
  • 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

Who Should Attend

This Webinar will provide invaluable assistance to all license owner 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 Compliance
  • CMC Personnel
  • Packaging Experts
  • Auditors and Staff
  • Consultants

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.


Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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