COURSE "SUPPLIER RISK MANAGEMENT" HAS BEEN PRE-APP 2013 - Supplier Risk Management - Webinar By GlobalCompliancePanel

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Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: March 12, 2013 | Date: March 12, 2013

Venue/Country: California, U.S.A

Updated: 2013-02-22 15:30:44 (GMT+9)

Call For Papers - CFP

Purchasing controls for medical devices are defined in the Code of Federal Register (CFR) in 21 CFR 820.50. Component suppliers do not have an independent obligation to comply with the Quality System Regulation (QSR) as defined by the Food and Drug Administration (FDA). The onus lies on the finished device manufacturer to specify via a contract or purchase order the level at which suppliers must comply with the QSR. For many smaller suppliers compliance with the QSR is not cost effective, leading the finished medical device manufacturer to use auditing and inspection of components as the only method for controlling suppliers.

Areas Covered in the Session: Compliance with the FDA's purchasing controls can be defined in five (5) steps:

Supplier evaluation

Determination of the level of control to exercise over the supplier

Recordkeeping or documentation of activities

Maintaining and/or disseminating purchasing information

Receiving acceptance activities

Who Will Benefit:

Management

Research and Development

Regulatory Affairs Personnel

Quality Assurance/Quality Control Personnel

Auditors and Inspectors

Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.

Price: $225.00

GlobalCompliancePanel

Phone: 800-447-9407

Fax: 302-288-6884

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