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Webinar Search Results
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Topic: Not Specified Category: All Speaker: Edwin L Bills Month: Any
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Edwin L Bills
Why Medical Device Companies Receive Warning Letters
The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical device companies.
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
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Edwin L Bills
Control of Products and Services Obtained from Suppliers
The US FDA has discovered that a reasonably large number of recalls and adverse events are related to supplied product.
Recorded View Anytime
$295.00
Edwin L Bills
Process Validation for Medical Device Manufacturers
All medical device companies are required to review its manufacturing processes to determine which processes require process validation, and which processes may be qualified by other methods.
Recorded View Anytime
$295.00
Edwin L Bills
The New FDA-Product Approval, Inspection, and Enforcement
The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.
Recorded View Anytime
$295.00
Edwin L Bills
Integrating Risk Management Into the Quality System
ISO 14971 medical device risk management standard was updated in 2007 after its initial release in 2000.
Recorded View Anytime
$295.00
Edwin L Bills
Proper Documentation of Risk Management for Compliance with ISO 14971
This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and improved time to market with a lower risk product.
Recorded View Anytime
$295.00
Edwin L Bills
Use of Risk Management during Process and Design Validation
This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three areas.
Recorded View Anytime
$295.00
Edwin L Bills
How does Risk Management Impact Supply Management
This course will demonstrate how to use risk management tools effectively to select suppliers that impact safety and to communicate to suppliers where they need to apply special attention to reduce the risk of their products to the medical device manufacturer.
Recorded View Anytime
$295.00
Edwin L Bills
Why Medical Device Companies Receive Warning Letters
The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical device companies.
Recorded View Anytime
$295.00
Edwin L Bills
Post-Design Medical Device Risk Management
In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements.
Recorded View Anytime
$295.00
Edwin L Bills
Use of Risk Management to Meet Requirements of IEC 60601-1
This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements.
Recorded View Anytime
$295.00
Edwin L Bills
Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety
In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device.
Recorded View Anytime
$295.00
Edwin L Bills
Interfacing Design Verification, Process Validation and Design Validation
There is confusion between the requirements for Design Verification, Process Validation and Design Validation.
Recorded View Anytime
$295.00
Edwin L Bills
CAPA and Risk Management
Manufacturers continue to struggle with CAPA systems as evidenced by FDA Warning Letters which show a large percentage of citations are for inadequate CAPA Systems.
Recorded View Anytime
$295.00
Edwin L Bills
Understanding the new IEC 60601-1 Third Edition
Now that the FDA has become the last regulator to indicate they will recognize IEC 60601-1 Third Edition, it is important that device manufacturers understand this standard as they need to begin implementation in current and future design projects of electro-medical devices.
Recorded View Anytime
$295.00
Edwin L Bills
Business, Project and Compliance Risk
Companies have been applying the techniques of ISO 14971 to product safety, but the techniques can also be applied to other risks encountered in all companies.
Recorded View Anytime  Duration:90 Minutes
$295.00
Edwin L Bills
Risk Management in IEC 60601-1 Third Edition
IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.
Recorded View Anytime
$295.00
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