Live web seminar Supplier Management?Do you comply with the latest FDA and ISO 13485 requirements

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Category Medical Device

Deadline: June 29, 2015 | Date: June 30, 2015

Venue/Country: Online, U.S.A

Updated: 2015-05-29 15:31:05 (GMT+9)

Call For Papers - CFP

This 90-minute webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while using risk information so you may reduce your cost of compliance.

Why you should attend :

This presentation will provide an understanding of the two important guidelines now being use by FDA and ISO 13485 Notified Body auditors. This will allow you to make sure your supplier management and control system meet these guidelines, especially for outsourced processes such as contract manufacturing, distribution, sterilization and testing. You depend on your suppliers, but can your system prove that you have sufficient control over your suppliers, especially your critical suppliers, to assure auditors and regulatory agencies that your product is safe and meets all your requirements?

If you understand, define, document and control the risks related to all of your suppliers, as the guidelines require, you will make your supplier management program more cost effective. There are specific documentation expectations in the areas of risk and supplier control that you must be aware of and use, which this seminar will explain how to implement.

Remember Notified bodies and the FDA, cannot require your suppliers to meet the same quality system regulations that you do, so they must make sure you are exercising sufficient control over those suppliers.

Description of the topic :

This webinar will provide valuable assistance in:

Developing or updating your supplier control system to one based on risk

Complying with ever more stringent expectation of ISO 13485 auditors related to suppliers

Understand the special requirements related to contract manufacturers, distributors, and other critical suppliers

Determining different ways to assess suppliers based upon risk

Learning the importance of developing solid contractual agreements with key suppliers

Understanding the importance of supplier quality and its relevance to ISO 13485 and FDA’s quality system requirements

When might your supplier be subject to an unannounced audit by your notified body

Areas Covered In the Seminar

The types of suppliers that must be qualified according to the FDA and ISO 13485

Explanation, and use of the Global harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to

How to create or bring your supplier program into compliance with the these guidance documents

Definition of and requirements for Critical suppliers

Defining and controlling supplier risk and why this benefits you

Supplier qualification and control, best practices

Unannounced Notified body audits

Who will benefit

This webinar will provide valuable assistance to all personnel in:

Quality Management

Regulatory Affairs

Supply-chain Management

Supplier engineering

Purchasing Management

Supplier auditing

Internal auditing

Quality engineering

Free documents for Attendee

Form for Supplier Evaluation, word processing format

Guidance documents:

GHTF sg3final-N17, Guidance on the Control of Products and Services Obtained from Suppliers

NBOG_BPG_2010,1-Guidance on auditing suppliers

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance