Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) 2017

Topics

• 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

Who should Attend

• 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