ComplianceOnline

Full Day Virtual Seminar - US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

Instructor: Robert J Russell
Product ID: 703109
  • Duration: 6 hrs

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 6 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

Course "Full Day Virtual Seminar - 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 6 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

This full-day ICH GMP training course will provide your company the opportunity for a 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.

Agenda: (All time in EDT):

  • 10:00 am EDT to 12:00 noon (Agenda Sections I – V below)
  • 12:00 noon to 1:00 pm (Lunch)
  • 1:00 pm to 3:00 pm (Agenda Sections VI – X below)
  • 3:00 to 3:15 pm (Break)
  • 3:15 to 4:00 pm (Conclusions and Final Comments)
  • 4:00 pm (Q&A Session)

Areas Covered in the Seminar :

US, EU, Japan GMP Requirements(Practical ICH Area Differences, Healthcare Authority Inspection Focus)

I .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.

II . Where Inconsistencies Become a Problem: WHO, ICH, Countries

  • Flexibility in global expectations.
  • Most challenging topics where alignment varies.

III . Key Chapter Reviews

  • ICH GMP organization.
  • Category reviews.

IV . 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.

V . GMP Comparisons for APIs

  • Auditing API facilities.
  • Typical audit agenda.
  • ICH Area differences.

VI . GMP Comparisons for Finished Products

  • Auditing finished product facilities.
  • Typical audit agenda.
  • ICH Area differences.

VII . GMP Comparisons for ……

  • Excipients.
  • Sterile products.
  • Biologics.
  • Clinical Packaging.

VIII . 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.

IX . Outsourcing Management…….a Regional Perspective on:

  • Contract manufacturing.
  • Contract packaging.
  • 3 rd Party Contract testing.

X . 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.

XI . Conclusions / Wrap-Up

Who Will Benefit:

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

Instructor Profile:

Robert J. Russell , (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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