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