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

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

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.

Executive Management

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

Email: TW9oYW1tYWQgISBJcnNoYWQgfCBDb21wbGlhbmNlT25saW5lICEgQ29t

Map Singapore, Bishan, Singapore
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