Effective Purchasing and Supplier Controls for Medical Device Manufacturers
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma"
Understand your responsibilities in terms of Purchasing Controls
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality.
But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers and set forth the applicable criteria they must meet to remain 'approved.' You never have to pay a visit to your supplier if you have a great supplier control program in place.
Why Should you Attend
Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations.
• Objectives of the Presentation
• Understanding the regulations
• Lessons Learned
• FDA Expectations
• Authority and Scope
• Purchasing Controls Process
• Evaluation of Suppliers
• Purchasing Data
• Performance Management
• Feedback and Communication
• Best Practice
Who will Benefit
• Supplier Engineers
• Supplier/Purchasing Managers
• Quality Engineers
• Supplier Quality Engineers
• Compliance Personnel
• Supplier Auditors
• Compliance Specialists
• Manufacturing engineers
• Management Representatives
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel