Course offering number:0810-705
Course ID:
2227
Assuring Your Supply Chain through Supplier Qualification
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
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