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Course |
Dates |
Where |
Tuition |
Enroll |
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Join us to enhance your knowledge and skills and obtain application tools during a 12-month series focused on all aspects of design controls.
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09/18/2012 - 08/20/2013
12-month Series
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On Location
Webinar |
Industry: $4500.00
†Small Companies: $3600.00
††Consultants: 2250.00
†††Startup/Academic: 900.00
Government Official: $0.00
More Info >
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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?
**Register for all 3 webinars and receive a 10% Discount!**
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TBD
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?
**Register for all 3 webinars and receive a 10% Discount!**
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TBD
*Now Available On Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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**Available for Immediate Access** This 1.5-hour Webinar includes an overview of regulations and guidances, as well as interdependencies and functional responsibilities.
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09/18/2012 - 09/18/2012
*Now Available On Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar explores the requirements for design planning and design history files and implementation tools to meet the requirements.
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10/23/2012 - 10/23/2012
*Now Available On Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar explores the requirements for design inputs (including sources for design inputs) and implementation tools to meet the requirements (including how to write good design inputs).
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11/14/2012 - 11/14/2012
*Now Available On Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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In one full day session, participants will learn the requirements for successfully completing a 510(k) and what to expect from the FDA's newest developments and changes.
This program will be hosted at Steris (Cleveland) but is open to everyone.
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11/15/2012 - 11/15/2012
COMPLETE-Past Course
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On Location |
Industry: $795.00
†Small Companies: $636.00
††Consultants: 397.50
†††Startup/Academic: 159.00
Government Official: $0.00
More Info >
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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?
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12/12/2012 - 12/03/2013
1:00pm - 2:30pm (EST)
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Webinar |
Industry: $937.00
†Small Companies: $749.52
††Consultants: 468.45
†††Startup/Academic: 187.38
Government Official: $0.00
More Info >
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This 2-day, on-location workshop will include sessions on Risk Management, Safety Assurance Cases and the 14971.
On-Location in Cleveland, hosted by Steris (open to everyone)
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01/23/2013 - 01/24/2013
COMPLETE-Past Course
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On Location |
Industry: $1295.00
†Small Companies: $1036.00
††Consultants: 647.50
†††Startup/Academic: 259.00
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the requirements for risk management and implementation tools to meet the requirements.
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02/19/2013 - 02/19/2013
*Now Available on Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the requirements for Software Validation and implementation tools to meet the regulatory requirements.
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03/19/2013 - 03/19/2013
*Now Available on Demand!*
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5 hour webinar will cover key criteria of Design Verification and Validation.
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04/12/2013 - 04/12/2013
**Now Available On Demand!**
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5 hour introductory webinar will take a broad look at the overall system of post-market surveillance and how it relates to other critical processes. A dynamic Question and Answer session will be held at the end of the presentation.
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04/25/2013 - 04/25/2013
*Now Available on Demand!*
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On Demand |
Industry: $347
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 6 webinar course series will focus on the key aspects of a robust post-market surveillance system including: a broad overview perspective, complaint handling, MDR, vigilance, corrections & Removals, and operational strategy. Join FDA and industry experts for this dynamic series that will enhance your post-market system.
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04/25/2013 - 09/26/2013
1:00pm - 2:30pm
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Webinar |
Industry: $1874.00
†Small Companies: $1499.00
††Consultants: 936.90
†††Startup/Academic: 374.76
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the requirements for Design Reviews and implementation tools to meet the regulatory requirements. Additionally, this module will cover what types of metrics should be considered to track overall health of your product design and your design control process.
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05/09/2013 - 05/09/2013
**Now Available On Demand!**
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the requirements for Design Outputs and Design Transfer and implementation tools to meet the regulatory requirements.
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05/21/2013 - 05/21/2013
**Now Available On Demand!**
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On Demand |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5 hour introductory webinar will take a broad look at the overall system of post-market surveillance and how it relates to other critical processes. A dynamic Question and Answer session will be held at the end of the presentation.
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05/23/2013 - 05/23/2013
**Now Available On Demand!**
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On Demand |
Industry: $347
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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Join this 1.5 hour webinar for a deep dive into the key components of a MDR report and how to meet FDA expectations.
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06/20/2013 - 06/20/2013
1:00pm - 2:30pm
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Webinar |
Industry: $347
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the requirements for Design Changes and implementation tools to meet the regulatory requirements. Participants will discuss an approach to analyze impact of design changes to ensure all portions of your design controls are addressed (e.g., repeating verification testing, updating risk management file, updating component specification, repeating process validation).
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06/25/2013 - 06/25/2013
1:00pm - 2:30pm (EST)
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5-hour Webinar will explore the regulations related to defect management, key process interdependencies (e.g., with CAPA and Complaint Handling), and possible approaches to managing and handling design defects.
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07/23/2013 - 07/23/2013
1:00pm - 2:30pm (EST)
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5 hour webinar discusses the importance of vigilance in all areas of post-market surveillance.
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07/25/2013 - 07/25/2013
1:00pm - 2:30pm
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This module of the Design Control Series will involve interaction with Design Controls experts from FDA and Industry. Topics will include Inspection Readiness and Design Change. The day is planned with small group discussion and interaction with FDA presenters. The participants will leave the day with Action Plans in hand.
The day will begin with a certification exam for those qualifying for certification. For those taking the exam remotely, details will be provided on how this will be facilitated.
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08/20/2013 - 08/20/2013
8-hour Session
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On Campus |
Industry: $795.00
†Small Companies: $636.00
††Consultants: 397.50
†††Startup/Academic: 159.00
Government Official: $0.00
More Info >
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This 1.5 hour webinar covers the full gamut corrections, removals and recalls
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08/22/2013 - 08/22/2013
1:00pm - 2:30pm
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
|
|
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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?
**Register for all 3 webinars and receive a 10% Discount!**
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09/11/2013 - 09/11/2013
1:00pm - 2:30pm (EST)
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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This 1.5 hour webinar focuses on how to make Post-Market Surveillance work in a global company and will include a dynamic panel discussion that will answer your questions to make your company system stronger.
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09/26/2013 - 09/26/2013
1:00pm - 2:30pm
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Webinar |
Industry: $347.00
†Small Companies: $277.60
††Consultants: 173.50
†††Startup/Academic: 69.40
Government Official: $0.00
More Info >
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