Effective Purchasing & Supplier Controls in Accordance with 21 CFR, Part 820.50

$299.00

Description:

Lack of an effective approach to purchasing controls and supplier management is one of the more frequent Form 483 observations cited during FDA device establishment inspections. Additionally, problems with purchasing controls are typically rooted in a lack of effective supplier controls, which also falls under the realm of §820.50. In fact, the lack of effective purchasing and supplier controls often result in product recalls due to nonconforming product finding its way into the supply chain.

If your organization is struggling with understanding the salient requirements associated with purchasing and supplier controls, this webinar is for you. This webinar will help your organizations better understand the FDA’s expectations for purchasing and supplier controls, while providing insight into tools needed for establishing an effective approach for purchasing and supplier management. For establishments already having a compliant purchasing controls system, this webinar will help your organization streamline their approach to purchasing and supplier management.

Areas to be Covered:

Reviewing and understanding the requirements associated with 21 CFR, Part 820.50 compliance.
Similarities with ISO 13485, Clause 7.4.
Understanding current industry practices.
Purchase orders, contracts, & supplier agreements.
Establishing a proactive approach to supplier evaluations.
Understanding the components of supplier risk.
Managing suppliers.
The supplier selection process.
Employing categories for supplier management.
Supplier quality agreements.
No-change agreements.
Establishing supplier metrics and report cards.
Supplier Corrective Action Requests (SCARs).
Supplier Removal process from the Approved Supplier’s List (ASL)
Assessing tier 2 suppliers.
Acceptance activities (receiving inspection).
Recent FDA enforcement activities.

Who will Benefit:

A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s purchasing and supplier management process. The staff who will benefit include:
Quality Professionals
Regulatory Professionals
Test Technicians
R & D Engineers
Manufacturing Engineers
Quality Engineers

Dr. Christopher J. Devine

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.

$299.00

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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