Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2019

October 2019 (Not Final)
Singapore

Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2019 might be held in Singapore in October 2019 (Not Final).

Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2019 is a conference that covers topics such as:

  • The vocabulary Quality Management including expectations for a Quality Culture
  • The history and expectations for global regulators for Quality Management and a State of Control
  • The role and importance of Documentation
  • Aspects related to Quality Management from the following sources
    • ICH-Q8 Quality by Design for new and generic drugs
    • ICH-Q7 GMPs
    • ICH-Q10 Pharmaceutical Quality System
    • ICH-Q9 Risk Management
    • 21CFR 210/211/820 for GMPs
    • ICH-Q11 Development & Manufacture of Drug Substance
    • 21CFR Part 11 & Annex 11
    • 21CFR 314 for Post Market Surveillance
    • MHRA`s Guidance on Data Integrity
  • How to prepare and present the State of Control to investigators during an inspection
  • The interaction and integration required for successful GMP operations

Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2019 brings together:

  • Plant and Global Senior Quality Managers
  • Executive Management
  • Plant and Global Regulatory Professionals
  • Plant and Global Quality Professionals
  • Production Managers, Supervisors and Operators
  • Plant and Global Compliance Professionals
  • Warehouse Managers and Supervisors
  • Manufacturing Managers & Supervisors
  • Process and Department Owners
  • Calibration, Preventive Maintenance and Production Supervising Engineers
  • Quality Auditors
  • Quality Engineers
  • Plant and Global Designated Investigators and Process Improvement Personnel
  • Deviation & CAPA System Personnel

Venue

Singapore
  View all Hotels near Venue
Booking.com
1699-1899 US Dollar
No exhibition
Rentalcars Savings

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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