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

Speaker

Instructor: Robert J Russell
Product ID: 702029

Location
  • 25
  • October 2024
    Friday
  • 10:00 AM PT | 01:00 PM ET
    Duration: 90 Min
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.
LIVE ONLINE TRAINING

October 25, Friday 10:00 AM PT | 01:00 PM ET
Duration: 90 Min

 

$199.00
One Dial-in One Attendee

$999.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

$379.00

$529.00

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

Description:

The webinar 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

Areas Covered in the Webinar :

  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.
  2. Where Inconsistencies Become a Problem: WHO, ICH, Countries
    • Flexibility in global expectations.
    • Most challenging topics where alignment varies.
  3. Key Chapter Reviews
    • ICH GMP organization.
    • Category reviews.
  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.
  5. GMP Comparisons for APIs
    • Auditing API facilities.
    • Typical audit agenda.
    • ICH Area differences.
  6. GMP Comparisons for Finished Products
    • Auditing finished product facilities.
    • Typical audit agenda.
    • ICH Area differences.
  7. GMP Comparisons for ……
    • Active Ingredients
    • Finished products [drugs, biologics]
    • Excipient producers
    • Sterile products
    • OTC vs. Prescription
    • Implications for Contract Manufacturers
  8. 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.
  9. Outsourcing Management…….a Regional Perspective on:
    • Contract manufacturing.
    • Contract packaging.
    • 3 rd Party Contract testing.
  10. 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.
  11. Conclusions / Wrap-Up

Who Will Benefit:

This Webinar 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
Instructor Profile:
Robert J Russell

Robert J Russell
President, 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 22 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.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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