Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2020

  • Apr 2020
  • Singapore

Description

Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2020 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) 2020 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

Past Events

Important

Please, check "Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Health & Medicine: Pharma
Science: Life Sciences & Biology

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