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Management Review: The Complete Requirements
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One of the main elements to a fully implemented Quality Management System (QMS) is the Management Review.
Recorded
Thursday,
May 13, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$295.00
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Introduction to ISO 14971: Risk Management
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The term "Risk Based Processes" as become the latest trend in all aspects of medical device design, manufacture, test. distribution or service.
Recorded
Tuesday,
April 27, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$295.00
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Webinar on Specification Mapping
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In order for an organization to satisfy the requirements for Design Control, no matter what Quality Management System (QMS) is being followed, there needs to be traceability from the Product Requirement specification through the verification and validation processes.
Recorded
Tuesday,
April 13, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$295.00
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The FDA Electronic Submission Gateway (ESG)
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With the upcoming mandate by the FDA of the use of their Electronic Medical Device Reporting System (eMDR) all medical device manufacturers will be required to create and submit MDRs via the FDA's Electronic Submission Gateway or FDA ESG.
Recorded
Thursday,
March 25, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$295.00
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New Requirements for the Medical Device Directive (MDD)
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Back 0n September 5th 2007 the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market).
Recorded
Thursday,
March 11, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$295.00
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Risk Analysis: When does it start and When does it End
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As a result of attending this presentation, the attendee will receive an overview of Risk Analysis which can be applied to all varieties of Medical Devices in the marketplace today.
Recorded
,
$295.00
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Design History Files: Their Content and Control
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After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still met, what not to have as part of the DHF and how all of the international regulations overlap in their Design History File requirements.
Recorded
,
$295.00
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Report Requirements for Radiation Emitting Products; CeSub & ESG
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By attending this webinar the attendee will become familiar with how the process works and what need to be done for access to the FDA ESG.
Recorded
,
$295.00
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GMP Training for Manufacturing and Administration Personnel
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If you read the FDA quality system regulation clause 820. 25 (personnel) it states that: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
Recorded
,
$295.00
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MDD Essential Requirements: An Overview
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Any medical device manufacturer seeking market clearance in the European Community must meet and follow the Medical Device Directive or MDD. Since its original release in1993 there have been several updates to this directive, the most significant of which was in September of 2007 with the release of Directive 2007/47/EC of the European Parliament and of the Council.
Recorded
,
$295.00
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Device Master Record & Device History Record: A Regulatory Overview
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After completion of this webinar the attendee will have a thorough understanding of the what these two important parts of a GMP compliant quality management system are, and how they are established, implemented and controlled.
Recorded
,
$295.00
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Design Changes: When is a New 510(k) Required
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This webinar will provide an overview of the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device".
Recorded
,
$295.00
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Quality System Records: Origin and Controls
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The establishment, implementation and maintenance of a Quality Management System (QMS) requires records to provide evidence of implementation to a third party or an internal audit organization.
Recorded
,
$295.00
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Verification & Validation: Their Similarities and Differences
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Before the design process is completed and your product or device is ready for the marketplace, verification and validation are imperative.
Recorded
,
$295.00
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Preparing a Medical Product Regulatory Requirement Plan
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Prior to the development of or the acceptance of a contract for development of a medical product, an important step is the development of a Regulatory Requirements Plan for the product.
Recorded
,
$295.00
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Elements of a Medical Device Requirement Specification
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In order to start the ball rolling for new medical device and after the Marketing folks have provided R&D with their input, the Requirement Specification combines these processes.
Recorded
,
$295.00
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Developing a Complete Product Quality Plan
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The bridge between Product Concept and Customer delivery of a product, whether it be a medical device, a component or a commercial product, is the Product Quality Plan.
Recorded
,
$295.00
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Maintaining A Complete Design History File
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No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products.
Recorded
,
$295.00
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Design Changes and 510(k)
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All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices.
Recorded
,
$295.00
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...more
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Fax: 302-288-6884
