Quality System from Discovery to Commercialization - New Paradigm | October 1, 2015 10:00 AM - October 1, 2015 1:00 PM | Automation.com

Quality System from Discovery to Commercialization - New Paradigm

Event Summary

October 1, 2015
October 1, 2015 10:00 AM
October 1, 2015 1:00 PM
[email protected]
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This intensive 90-minute online training course focuses on gaining up-to-date knowledge on the GXPs quality system that is based on USA FDA and ICH international standards quality concepts, including applicable Current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations.

Why Should you Attend

This course is designed to show how a modern, comprehensive quality system that provides for full compliance with regulations can be applied throughout the product lifecycle (GXP).A a new paradigm!

The materials are put together for Biotech and Pharmaceutical companies to help them with the establishment and implementation of a dynamic, efficient, compliant quality/regulatory system that can be utilized throughout the product life cycle and is cost-effective.

The training course cross-references how and where specific GXP regulations fit within the comprehensive modern quality, while discussing the similarities. Also provides tools and insights for the established pharmaceutical and biotechnology firms on how to improve the overall efficiency and compliance of quality systems, both internally and externally at contract sites.

Objectives of the Presentation

Overview of current Good Documentation Practice (GDP), GLP, GCP and GMP
Organizational Structures, including Quality Unit, Management, Operation, R&D, etc.
Quality System (s) that can be applied throughout the product life cycle
Quality Unit (QU), Managements, Sponsor and Operation Roles and Responsibilities
Document Infrastructure, including Standard Operating Procedures (SOPs) and Manuals

A checklist including all applicable reference and sections of the following regulations will be provided as a tool:

CFR Code of Federal Regulations-FDA (US)
Guidance: FDA Guidance, Compliance, & Regulatory Documents
ICH: International Conference on Harmonization-International
OECD: Organization for Economic Cooperation and Development) official guidance for nonclinical safety testing and principles of GLP-International
EU EudraLex: European Roles and Regulations.

Who can Benefit

This online training will benefit Pharmaceutical and Biopharmaceutical industries whose activities include compliance with current regulations throughout product life cycle, including Current GMP, GCP and GLP. This online training will benefit professionals in the following Biotech/Pharmaceutical Industries:

Management and Sponsors
Quality Unit, including Quality Assurance and Quality Control
Regulatory Affairs
Manufacturing and Production
R&D and CROs
Contract service providers
Other departments having to do with regulatory compliance

Note: Use Coupon code 1371 and get 10% off on registration.


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