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Provided by: BSI America Overview of ISO 13485 2003 - 2 HoursMedical |
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Training
Provided by BSI America
Wednesday August 5, 2009, 1: 00 pm to 3: 00 pm ET
Provides a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485: 2003. Students learn how ISO 13485: 2003 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products.
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Overview of ISO 13485 2003 - 2 Hours
Wednesday August 5, 2009, 1: 00 pm to 3: 00 pm ET
Provides a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485: 2003. Students learn how ISO 13485: 2003 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products.
Learning objectives
* Interpret Clauses of ISO 13485: 2003
* Recognize the basic requirements of 13485: 2003
* Learn the Benefits of Implementing ISO 13485: 2003
* Understand the Role of Management in ISO 13485: 2003 Implementation
* Recognize the Relationship between Risk Management and ISO 14971: 2001
* Understand the Linkage between ISO 13485: 2003 and GMPs
Who should attend
* Quality managers in the medical device industry
* Individuals who seek an understanding of the key concepts of ISO 13485: 2003
* Individuals involved in the transition from ISO 13485: 1996 to ISO 13485: 2003
* Cross functional team members implementing ISO 13485: 2003
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.
Provides a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485: 2003. Students learn how ISO 13485: 2003 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products.
Learning objectives
* Interpret Clauses of ISO 13485: 2003
* Recognize the basic requirements of 13485: 2003
* Learn the Benefits of Implementing ISO 13485: 2003
* Understand the Role of Management in ISO 13485: 2003 Implementation
* Recognize the Relationship between Risk Management and ISO 14971: 2001
* Understand the Linkage between ISO 13485: 2003 and GMPs
Who should attend
* Quality managers in the medical device industry
* Individuals who seek an understanding of the key concepts of ISO 13485: 2003
* Individuals involved in the transition from ISO 13485: 1996 to ISO 13485: 2003
* Cross functional team members implementing ISO 13485: 2003
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...
