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Webinar Search Results
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Your search returned 16 results
David R. Dills
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
David R. Dills
Managing Product Medical Device Recall Efficiently and Effectively
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
Live  Thursday, September 30, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
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David R. Dills
Conducting Successful Product Complaint Investigations
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.
Recorded View Anytime
$295.00
David R. Dills
How to Manage a Medical Device Recall Efficiently and Effectively
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Recorded View Anytime
$295.00
David R. Dills
Changes to the Medical Devices Directive 93/42/EEC
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
Recorded View Anytime
$295.00
David R. Dills
Managing Product Medical Device Recall Efficiently and Effectively
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
Recorded View Anytime
$295.00
David R. Dills
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.
Recorded View Anytime
$295.00
David R. Dills
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
Recorded View Anytime
$295.00
David R. Dills
Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review?
Recorded View Anytime
$295.00
David R. Dills
Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Recorded View Anytime
$295.00
David R. Dills
Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008.
Recorded View Anytime
$295.00
David R. Dills
Update on Unique Device Identifier for Device Manufacturers
Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
Recorded View Anytime
$295.00
David R. Dills
Managing Your Medical Device Reporting (MDR) Program for Compliance Success
Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.
Recorded View Anytime
$295.00
David R. Dills
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Recorded View Anytime
$295.00
David R. Dills
FDA's Update on Medical Device Labeling Changes
FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product.
Recorded View Anytime
$295.00
David R. Dills
Establish and Maintain an Effective Supplier Qualification Program
This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.
Recorded View Anytime
$295.00
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