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What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections?

: 7 Jun 2019

Sector: Clinical, Pharmaceutical

Type: Training, Webinar


ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This 3 hour webinar will 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.

 

Areas Covered in the Session:

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

  • U.S., EU and Japan GMPs - Status of Harmonization& FutureTrends
  • Where Inconsistencies Become a Problem: WHO, ICH, Countries
  • Key Chapter Reviews
  • Compliance with ICH Guidelines for GMPs
  • APIs
  • Finished Products
  • Excipients
  • Sterile products
  • Biologics
  • Clinical Packaging
  • Area GMP Inspections
  • Outsourcing Management Regional Perspective on:
  • Auditing Your Facilities for Global Considerations

Who Will Benefit:

  • Quality Assurance
  • Senior management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory Compliance

Find out more / register here:

Venue


Organizer

Compliance4All
Phone: +1-800-447-9407
Email: support@compliance4All.com
Visit: http://www.compliance4all.com/control/main


<< Previous article
STERIS Life Sciences...
Next article > >
Introduction to Phar...