Conference Description:
Why you should attend: The world is experiencing increasingly dysfunctional outcomes within end-to-end supply chains for pharmaceutical products. In response, FDA and regulators globally have placed improvement in supply chain integrity and product quality as an urgent priority. Key to meeting the rapidly escalating regulatory expectations is effective management of uncertainty and the associated risk of supply chain failure. Risk offers itself in many guises, for example, quality issues with a raw material that lead to product shortages, theft or counterfeiting of high value products and economically motivated adulteration of materials leading to patient death (eg Heparin, 2008).
The over-riding message is that risk abounds in the supply chain and only properly structured and executed risk management approaches are likely to gain regulatory acceptance going forward. The International Conference on Harmonization has issued guidance on Risk Management (ICH Q9) which lays out the expectations for a structured Risk Management process and explains some of the tools such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Along with this however, it is vitally important to understand the specifics of how, when and where to apply the tools and how to get at the deeper organizational issues that often underpin supply chain risk; also, how to create the important upstream and downstream linkages that are so necessary to maintain security.
Without a clear understanding of your business risk exposures in the supply chain and plans for managing those risks in a professional manner, it will become increasingly difficult to operate in the complex, interdependent pharmaceutical industry of the 21st century.
Areas Covered In the Session:
Risk assessment
Risk control
Risk review
Typical supply chain risk areas
ICH Q9
Supply chain management (SCM) best practices
Upcoming Regulatory changes
Who will benefit:
Preclinical Development
Clinical Development
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Purchasing
Procurement
Supply Management
Operations
Production Management
Warehouse Management
Import/export
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Start Date: 2011-12-13
Last Day: 2011-12-13
Contact Person: webinars
Email: webinars@globalcompliancepanel.com
Address:
online training, Wilmington, DE, 19801, United States
Tel: 8004479407
Fax: 3022886884
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