Course offering number:0810-104
Course ID:
2227
Assuring Your Supply Chain through Supplier Qualification
October 2, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
90 Minute Accredited Online Training
Who Should Attend
This course will benefit professionals in all industries with special significance for the following regulated
sectors: Pharmaceuticals, Food, Biotechnology, Medical Device, Dietary Supplement, Cosmetics, etc.
The information will be pertinent to personnel in the following job functions who are involved in supplier
selection, qualification, or oversight: Scientists, Formulators, Auditors, Managers, Purchasing Agents
Appropriate attendees may work in the following departments: Research and Development, QA/QC,
Regulatory, Purchasing
Description
This 90-minute accredited online training will discuss important elements of a sound supplier qualification
program. Discussions will focus on the considerations in selecting a supplier and the techniques for
assessing the supplier's quality system. Special attention will be directed toward the evaluation of supplier
product quality, supply chain concerns, and notification of change. This presentation will include the latest
thinking by the FDA on this matter.
Module 1: SUPPLIER SELECTION
Criteria:
Business relationship
Regulatory considerations
Technical expertise
Quality System requirements:
ISO 9001 Certification
Food GMP
Excipient GMP
Quality System Assessment Techniques:
Questionnaire
Second Party Audit
Third Party Audit
Module 2: AUDITING THE SUPPLIER
Audit Standards:
ISO 9001
Food GMP
Excipient GMP
Assessment Organizations:
ISO registrars
GMA Safe and AIBN
USP Certified and IPEA
Module 3: EVALUATION OF SUPPLIER PRODUCT QUALITY
Requesting evaluation samples
Process capability and Validation
Lot Selection
Notification of Change:
Importance of notification
Evaluation of changes
Supply Chain issues:
Purchasing from a Distributor:
Distributor operations
Distributor Quality System Requirements
Identifying the manufacturer:
Establishing Pedigree
Question and Answer Session