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Design Controls Series:
Certificate Program

Join us to enhance your knowledge and skills and obtain application tools during a 10-part series focused on all aspects of design controls.

-Now Available On Demand -

Webinar Industry: $3150.00
†Small Companies: $2475.00
††Consultants:
†††Startup/Academic: 675.00
Government Official: $0.00

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Design Controls Module 1:
Introduction to Design Controls

**Available for Immediate Access** This 1.5-hour Webinar includes an overview of regulations and guidances, as well as interdependencies and functional responsibilities.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

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Design Controls Module 2:
Design Planning and Design History File

This 1.5-hour Webinar explores the requirements for design planning and design history files and implementation tools to meet the requirements.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

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Design Controls Module 6:
Design Verification and Validation

This 1.5 hour webinar will cover key criteria of Design Verification and Validation.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

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Design Controls Module 3:
Design Inputs

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).

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

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Design Controls Module 4:
Risk Management

This 1.5-hour Webinar will explore the requirements for risk management and implementation tools to meet the requirements.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Design Controls Module 5:
Software Validation

This 1.5-hour Webinar will explore the requirements for Software Validation and implementation tools to meet the regulatory requirements.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

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Design Controls Module 7:
Design Reviews and Design Quality Experts

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.

-Now Available On Demand -

On Demand Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Design Controls Module 8:
Design Outputs and Transfer

This 1.5-hour Webinar will explore the requirements for Design Outputs and Design Transfer and implementation tools to meet the regulatory requirements.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Design Controls Module 9:
Design Changes

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).

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Design Controls Module 10:
Design Defect Management

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.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 1)

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!**

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 2)

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!**

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 1:
Introduction to Post-Market Surveillance

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.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series

This six 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.

-Now Available On Demand -

Webinar Industry: $1890.00
†Small Companies: $1485.00
††Consultants:
†††Startup/Academic: 405.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 2:
Complaint Handling

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.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 3:
Medical Device Reporting (MDR)

Join this 1.5 hour webinar for a deep dive into the key components of a MDR report and how to meet FDA expectations.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 5:
Corrections & Removals or Recalls

This 1.5 hour webinar covers the full gamut corrections, removals and recalls

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 6:
Operationalizing Post-Market Surveillance in a Global Company

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.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Post-Market Surveillance Series Module 4:
Vigilance

This 1.5 hour webinar discusses the importance of vigilance in all areas of post-market surveillance.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

How to Implement the Unique Device Identification Requirements-MedCon 2014 Webinar

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Advanced Post-Market Surveillance Series

This two-part series will focus on Advanced Post-Market Surveillance topics. We highly recommend (but not require) that you view the six-part Post Market Surveillance Series prior to this two-part advanced series in order to achieve maximum understanding and value. This series builds on and utilizes information shared in the Medical Device Reporting and Design Controls Series.

-Now Available On Demand -

Webinar Industry: $700.00
†Small Companies: $550.00
††Consultants:
†††Startup/Academic: 150.00
Government Official: $0.00

More Info >

Advanced Post-Market Surveillance Series Part 1:
Manage Post-Market Surveillance Functions Efficiently and Effectively

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Advanced Post-Market Surveillance Series Part 2:
Harmonizing Post-Market Surveillance Processes

- Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 1:
Setting the Strategy for your Company’s Submission Process

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 2:
Setting the Foundation for Successful Approval

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 3:
Verification of the Foundation

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

-Now Available On Demand -

On Demand Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 4:
Constructing a Robust Submission

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

-Now Available On Demand -

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 5:
Submission Review and Outcomes

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

-Now Available On Demand -

On Demand Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 3)

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!**

TBD

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >

2.1 Industry Structure and Stakeholders

TBD

Industry: $
†Small Companies: $
††Consultants:
†††Startup/Academic:
Government Official: $

More Info >

FDASIA - Complete Webinar Series

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?

12/12/2012 - 12/31/2014
12:00pm - 1:30pm (EST)

Webinar Industry: $945.00
†Small Companies: $745.00
††Consultants:
†††Startup/Academic: 200.00
Government Official: $0.00

More Info >

Regulatory Submission Series

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

06/17/2014 - 11/20/2014
12:00pm - 1:30pm

Webinar Industry: $1890.00
†Small Companies: $1485.00
††Consultants:
†††Startup/Academic: 405.00
Government Official: $0.00

More Info >

Regulatory Submission Series Module 6:
Post-market Submission Actions

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

11/20/2014 - 11/20/2014
12:00pm - 1:30pm (EST)

Webinar Industry: $350.00
†Small Companies: $275.00
††Consultants:
†††Startup/Academic: 75.00
Government Official: $0.00

More Info >