Meetings/Workshops on Regulation in Medicine and Pharmacology in Singapore

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Canada (1) - India (2) - Singapore (4) - Switzerland (1) - United Kingdom (1) - United States (10) - ALL COUNTRIES (19)

1
How to apply ISO 62304 standard in a medical software development project?
18 Mar 2019 - 19 Mar 2019 • Singapore, Singapore
Abstract:
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"ISO 62304 standard for medical software development, medical software development project, post market process, medical software risk management process, quality management system, ISO 13485, EU MDR, medical software maintenance process"
Event listing ID:
1182792
2
Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)? By:
20 Mar 2019 • Singapore, Singapore
Abstract:
This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"Medical Device Single Audit Program (MDSAP), MDSAP in existing QMS, European Notified Body Audits, MDSAP Management Processes, Adverse Event Reporting, Field Safety Corrective Actions"
Event listing ID:
1182879
3
How to Implement a Quality Management System According ISO 13485?
21 Mar 2019 - 22 Mar 2019 • Singapore, Singapore
Abstract:
Attend this seminar to learn medical device quality management standard ISO 13485. It will cover the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit is working.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"ISO 13485 seminar, quality management system, ISO 13485 Audit, medical device quality management system"
Event listing ID:
1182832
Related subject(s):
4
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:
1182862
Related subject(s):

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Last updated: 25 January 2019