Their products could get recalled, and the FDA could slap 483’s or Warning Letters, or impose other harsh penalties on them.
In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated benefits of outsourcing.
When it comes to high precision, high technology and critical products such as medical devices, outsourcing brings many benefits, but comes with enormous challenges. Because of the nature of the products, and the intended use they are put to; medical devices need proper controls when they are being entrusted to suppliers. Controls are a dire need for any product, but more so for such lifesaving products as medical devices.
Disastrous consequences of lack of proper controls
Failed products or components can have disastrous consequences on the patients, who are the end-users of these medical devices. Avoiding such situations is in the interest of everyone concerned, be it the patient or the manufacturer. While the adverse effects of the use of defective medical devices on the patients are known; medical device manufacturers too, stand to suffer when such products enter the market. They suffer a loss of reputation. Their products could get recalled, and the FDA could slap 483’s or Warning Letters, or impose other harsh penalties on them.
Most important of all, the FDA holds the manufacturer and not the supplier responsible for any such mishap. Therefore, the need for putting supplier controls in place is critical. They must comply with the standards and requirements for this aspect set out by the FDA, namely CFR 820.50.
If manufacturers choose to manufacture their products themselves, the onus is equally high, because in this instance, they must put the right purchasing controls in place. Purchase starts with the selection of the raw material for the product and could potentially include the purchase of all components, each of which should comply with the standards specified by the FDA.
A complete understanding on how to put effective purchasing/supplier controls in place
A detailed learning session which will offer proper understanding of the controls that need to be put in place for purchasing/supply of medical devices is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.
Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, and who brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities; will be the speaker at this webinar.
Please visit 483 and Warning Letter citations to enroll for this webinar and gain complete understanding of the controls that need to be put in place for purchasing/supplier of medical devices.
Susanne will give the participants of this webinar an understanding of their responsibilities in terms of purchasing controls, which will enable them to provide safe and effective products to your customers. She will show how to prevent quality and compliance problems by putting a strong system in place for purchasing controls.
She will familiarize participants with the regulations and how they can translate these into an efficient and effective process for purchasing/ supplier control. The essential elements of purchasing control and how these can be translated into their procedures will explained. Susanne will also discuss the process steps for purchasing control and how it relates to other parts of a manufacturer’s QMS including receiving and acceptance activities.
She will cover the following areas at this webinar:
- Understanding the regulations
- Lessons Learned
- FDA Expectations
- Purchasing Controls Process
- Evaluation of Suppliers
- Purchasing Data
- Performance Management
- Feedback and Communication
- Best Practices
- Inspection Readiness
This session will help personnel in the medical devices industry who are connected with supplier and purchase, such as Supplier Engineers, Supplier Auditors, Supplier/Purchasing Managers, Quality Engineers, Supplier Quality Engineers, Compliance Personnel, and Compliance Specialists.
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