Supplier Qualification – Important Part of Quality Systems and Supply Chain Management

This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of the quality system requirements (21 CFR 820), and companies must demonstrate control over their suppliers and the materials or services provided by them. This webinar will review the regulatory aspects of this program such as purchasing controls, evaluation of suppliers, contractors and consultants along with discussion of recent deficiencies found during their review by the inspectors.

A common approach to defining the level of control for suppliers is a risk-based approach where the higher the risk, the greater the level of control exerted. This can then be translated into whether or not on-site audits, mail-in audits or no audits are required. The webinar will provide a check list of items to be evaluated when selecting a potential supplier, and the topics to be included in a supplier agreement to answer the questions of what, when, how and who. Attendees will be given ample opportunity to ask questions regarding their current approach or to share ideas for improvement.

Attendees will walk away with not only the regulatory requirements for supplier agreements but a template of topics to use to evaluate or develop their own agreements.

Areas Covered in the Session :

  • Current regulatory requirements for supplier agreements as found in 21 CFR 820
  • Common topics to evaluate when conducting a risk-based supplier qualification
  • Typical things that should be covered in supplier agreements and the quality standards that should be examined
  • Review of the typical “tools” that companies should use to assure control of their suppliers and issues relating to the handling of changes
Who Should Attend:

  • Engineering Departments
  • Manufacturing Departments
  • R&D Departments
  • Quality Departments
  • Operations Departments
  • Supply Chain Departments
  • Purchasing Departments
  • cGMP auditors

FDB3065

Kenneth Christie

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.