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.
The supplier selection process.
Employing categories for supplier management.
Supplier quality 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:
R & D Engineers