Online Safety Community

Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

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
  • Planning
  • 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.

For more updates just click the below link controls for medical devices

Views: 12

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

John Robinson posted a blog post

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses…See More
yesterday
Adam Fleaming posted blog posts
yesterday
Alex posted a blog post

3 essential electrical safety tips for new students

Living away from home for the first time is an exciting, invigorating, and pretty daunting experience. While your first days at uni will be the time of your life, living away from your parents also comes with a new set of challenges.Aside from cooking and cleaning, one thing we take for granted is our parents’ knowledge of how to keep us safe. Electrical safety, in particular, is something not many first-time students know a lot about, but electrical accidents are…See More
yesterday
Training Doyens posted events
yesterday

Forum

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe on Thursday.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells on Wednesday.

What's your favorite motivational/safety quote? 102 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins on Tuesday.

Business Intelligence with Big Data happens at Unipê

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Barry Oct 26.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service