Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations): 2-Day Workshop, taking place on April 2-3, 2019 in Singapore. One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last.
This course will cover those ICH Guidances related to the Quality Systems for manufacturing:
ICH-Q7: cGMPs for Active Pharmaceutical Ingredients
ICH-Q8: Quality by Design for introducing new or generic products into manufacturing
ICH-Q9: Risk Assessment and the role of assessing Risk in the development, manufacturing, testing and supply chain of drugs.
ICH-Q10: Quality Management
ICH-Q11: Development and Manufacture of Drug Substances. (Read more)
Wednesday, March 6 is the last chance to register & save 15% on TOP of Early Bird pricing. Be sure to mention Coupon Code “324770” when checking out to avail flat 15% off..
Register Now => or follow the below link.
Learning Objectives: Upon completing this course participants should:
Understand the history and expectations for global regulators for Quality Management and a State of Control
Understand the vocabulary Quality Management including expectations for a “Quality Culture”
Understand aspects related to Quality Management from the following sources:
ICH-Q8 Quality by Design for new and generic drugs
ICH-Q9 Risk Management
ICH-Q10 Pharmaceutical Quality System
ICH-Q11 Development & Manufacture of Drug Substance
21CFR 210/211/820 for GMPs
21CFR 314 for Post Market Surveillance
21CFR Part 11 & Annex 11
MHRA’s Guidance on Data Integrity
Understand the role and importance of Documentation
Understand the interaction and integration required for successful GMP operations
How to prepare and present the State of Control to investigators during an inspection
Who will Benefit:
This course is designed for people throughout the GMP Operations with a focused emphasis on the Plant & Global Quality Units; Departmental Heads, Managers & Supervisors; and Plant Management. In addition, all GMP operations personnel could benefit, especially those selected SMEs within the organization who will face the inspectors.
Plant and Global Senior Quality Managers
Plant and Global Quality Professionals
Plant and Global Regulatory & Compliance Professionals
Production Managers, Supervisors and Operators
Manufacturing & Warehouse Managers & Supervisors
Calibration, Preventive Maintenance and Production Supervising Engineers
Process and Department Owners
Quality Engineers & Quality Auditors
Deviation & CAPA System Personnel
Plant and Global Designated Investigators and Process Improvement Personnel
To view the complete agenda, download the brochure. Register Now => Register Now Pay Later: to reserve your seat on 15% discount on TOP of early bird price; valid till March 6, 2019.
Just Fill this Pre-Registration Form (pdf) and email it to us. We will get back to you with your registration confirmation. In case of any change in your schedule, you can cancel or substitute your registration 30 days before the event date.
We look forward to seeing you and your team in Singapore. Regards, Mohammad Irshad
D: +1 650-332-0381