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Provided by: BSI America Overview of ISO 14971 2007 - 2 HoursMedical |
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Training
Provided by BSI America
Wednesday August 12, 2009, 1: 00 pm to 3: 00 pm ET
Provides information on the impact that ISO 14971: 2007 has on the decision making process of a medical device manufacturer. This webinar offers medical device professionals insight into how ISO 14971: 2007 can improve business and risk management efforts.
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Overview of ISO 14971 2007 - 2 Hours
Learning objectives
* Understand the Clauses of ISO 14971: 2007
* Discuss Statements of Applicability
* Understand How ISO 14971: 2007 applies to ISO 13485: 2003
* Understand How Management is Expected to Support the Implementation of ISO 14971: 2007
* Discuss Leveraging Existing Efforts to Help Meet ISO 14971: 2007 Requirements
* Identify the recent changes and how it will impact an organization wishing to sell devices globally
Who should attend
* Quality decision makers on management system strategy at Medical Device Manufacturing Firms
* Management Team of Medical Device Manufacturers
* Design Engineers, Process Engineers and Manufacturing Engineers
* Auditors of medical device manufacturing firms (internal and external)
* Consultants
* Regulators
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
Course logistics
A webinar is an interactive multimedia presentation that allows participants to hear the instructor through a telephone conference call while following the visual presentation through a webbased interface. The web element offers the ability to ask questions via a messaging tool and allows instant polls on topics discussed in the webinar. Access information is provided at registration. An internet connection with at least Microsoft Internet Explorer 6 and the ability to make a phone call while on the internet are required.
Digital certificates of attendance are provided at the conclusion of the course.
No refunds will be provided.
* Understand the Clauses of ISO 14971: 2007
* Discuss Statements of Applicability
* Understand How ISO 14971: 2007 applies to ISO 13485: 2003
* Understand How Management is Expected to Support the Implementation of ISO 14971: 2007
* Discuss Leveraging Existing Efforts to Help Meet ISO 14971: 2007 Requirements
* Identify the recent changes and how it will impact an organization wishing to sell devices globally
Who should attend
* Quality decision makers on management system strategy at Medical Device Manufacturing Firms
* Management Team of Medical Device Manufacturers
* Design Engineers, Process Engineers and Manufacturing Engineers
* Auditors of medical device manufacturing firms (internal and external)
* Consultants
* Regulators
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
Course logistics
A webinar is an interactive multimedia presentation that allows participants to hear the instructor through a telephone conference call while following the visual presentation through a webbased interface. The web element offers the ability to ask questions via a messaging tool and allows instant polls on topics discussed in the webinar. Access information is provided at registration. An internet connection with at least Microsoft Internet Explorer 6 and the ability to make a phone call while on the internet are required.
Digital certificates of attendance are provided at the conclusion of the course.
No refunds will be provided.
About The Training Provider: BSI America
BSI America - BSI Training is one of the world's leading providers of training, information and knowledge on standards, management systems, business improvement and the achievement of regulatory approval for products.
We lead the world in advocating, defining and implementing best practice across every field of human endeavour, from business continuity to food safety.
Since its foundation in 1901, BSI...
