Meetings/Workshops on Regulation in Medicine and Pharmacology in Singapore

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1
Pharmaceutical Quality Management System
02 Apr 2019 - 03 Apr 2019 • Singapore, Singapore
Abstract:
This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"pharma quality management workshop, good manufacturing practices (cGMP), ICH guidance for pharma quality management, ICH-Q7, ICH-Q8, ICH-Q9, ICH-Q10, ICH-Q11, Quality by Design (QbD), 21 CFR Part 11, MHRA guidance on data integrity, 21 CFR 314 for post market surveillance, ICH-Q9 Risk Management, SOPs, contamination control, vendor/supplier qualification, packaging operations, GMP lab, stability program, change Control"
Event listing ID:
1182917
Related subject(s):

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Last updated: 25 January 2019