Medical & Surgical

Jeff Kasoff

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible.
Live Wednesday, May 16, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

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. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
Live Thursday, May 17, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

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.
Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Markus Weber

Hazard Analysis vs. FMECA – Differences and Commonalities
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design.
Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals.
Live Wednesday, May 23, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jeff Kasoff

Process Validation Principles and Protocols for Medical Devices
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

David Nettleton

Computer System Validation: Step-by-Step
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.
Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

David Lim

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Steven S Kuwahara

Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted.
Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

David Nettleton

Excel Spreadsheet Validation to Eliminate 483s
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

John E Lincoln

Lean-Agile Project Management in a cGMP Environment
This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Live Wednesday, June 6, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Dan OLeary

Implementing Management Responsibility for Medical Devices
The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US.
Live Wednesday, June 6, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

David Lim

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media
This webinar will discuss the FDA's current thinking on good practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e.g., social media or other public electronic media). In addition, several public comments will be discussed in response to the FDA's recent guidance document.
Live Thursday, June 7, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Jeff Kasoff

Management Controls Under QSR and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together."
Live Tuesday, June 12, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

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. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting."
Live Tuesday, June 12, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

John Chapman

Verification vs. Validation in Regulated Industries
Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.
Live Thursday, June 14, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Live Thursday, June 14, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Edwin L Bills

Use of Risk Management during Process and Design Validation
In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation.
Live Tuesday, June 19, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

John E Lincoln

Prepare for Tougher cGMP Compliance Audits
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.
Live Wednesday, June 20, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Sylvie Le Glédic

Current Companion Diagnostic Regulatory Framework in the EU & US
This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic.
Live Wednesday, June 20, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Robert J. Russell

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
Live Thursday, June 21, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

David R. Dills

Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
Live Tuesday, June 26, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jeff Kasoff

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Live Wednesday, June 27, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

David Lim

How to submit a 510(k) and get it cleared from FDA
This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA.
Live Thursday, June 28, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

John Chapman

Regulatory Complaint Handling, MDR's & Recalls
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.
Live Tuesday, July 3, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

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. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device.
Live Tuesday, July 17, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

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