Series Description

Are you part of a design team to ensure product safety and efficacy? Are any of these areas of your responsibility?:

  • Design planning
  • Design inputs
  • Design outputs
  • Design verification and validation
  • Design changes
  • Design reviews
  • Design transfer
  • Design defect management
  • Design history files
  • Risk management

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

Receive a 15% discount for purchasing all 10 modules!
 

Expert Faculty

Julius Aviza
Quality Director
Allergan

Pat Baird
Product Design Owner
Baxter Healthcare

Richard Chapman
Chief, General Hospital Devices Branch in the Office of Device Evaluation (ODE) of the Center for Devices and Radiological Health,
FDA

Laureen Geniusz
Medical Device Specialist
FDA

Michelle Keyzer
Product Development and Engineering Manager
Baxter

Tina Krenc
Director, R&D Quality Assurance
Abbott Molecular

William MacFarland
Director, Division of Enforcement B, Office of Compliance
FDA/CDRH

Brian Motter
World-Wide Vice President, Quality and Compliance
DePuy Synthes

(Expert faculty titles and companies may have changed since the time of recording.)

 

Who Should Attend

All functions involved in Product Life Cycle activities including professionals in the areas of Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, Marketing, Service, and Clinical Affairs.

This series is ideal for:

  • Those already in the medical device industry who want a deeper understanding of design controls across the Total Product Lifecycle (TPLC).
  • Those in the pharmaceutical industry needing to understand the building blocks of medical devices.
  • Those involved in the combination products industry who require broader exposure to medical device controls.

 

Course Certificates

Each participant will receive a Certificate of Completion after each module attended upon the return of a completed evaluation form. Each participant will receive 0.1 CEU credits per hour of training. Access to webinar/s and link to the CEU evaluation form will be provided upon purchase.

Professional certification for Design Controls (1.0 CEU) will be given to those who complete all 10 courses and the final exam (which can be administered remotely).
 

Individual Modules

Click on the links below to get more information about individual modules:

Price

Registrants may purchase all 11 modules at a 15% discount, or may purchase individual modules at $99 each using the links above.

$840 for entire series (includes a 15% discount for purchase of all 10 modules)

Government Official: $0.00 (must have valid .gov email account)