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

Duration: 90 Minutes
This webinar reviews the latest developments in ICH Q7 GMP harmonization between US, EU and Japan. It describes how the advent of this guidance impacts the different countries and explains why the regulatory authorities of each country, still have divergent expectations, despite the harmonization. It then explains how to overcome the differences in the expectations of the US, EU and Japan regulatory authorities, to ensure successful inspections with minimum additional cost or effort.
GMP Training
Instructor: Angela Bazigos
Product ID: 500449

GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs), according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" being adopted by the regulatory bodies of the European Union (EU), Japan and USA.

Why Should you Attend:
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.

ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This webinarwill cover the key areas of how ICH Q7 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.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Objectives of the Presentation:
  • U.S., EU and Japan GMPs - Status of Harmonization& FutureTrends
    • Current status of harmonization of GMP requirements
    • Future Trends
  • Where Inconsistencies Become a Problem: WHO, ICH, Countries
    • Discrepancies in global expectations
    • Alignment issues
  • 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
  • APIs
    • Auditing API facilities
    • Typical audit agenda
    • ICH Area differences
  • Finished Products
    • Auditing finished product facilities
    • Typical audit agenda
    • ICH Area differences
  • Excipients
  • Sterile products
  • Biologics
  • Clinical Packaging
  • 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 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 can Benefit:
All License Owner personnel in the Pharmaceutical, Biotechnology, Medical Device and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise, for both full time and consulting personnel that would receive value from attending includes:
  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Senior management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory Compliance
  • CMC Personnel
  • Packaging Experts
  • Auditors and Staff
  • IT Subject Matter Experts
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
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