Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on August 03 for a discussion of the webinar

This webinar will focus on medical devices, IEC 62304, and what is required for compliance.

Medical devices can use very complex software applications, and any failure to function properly could lead to potential injury or death of a consumer or patient.

There is a need to improve overall standards for medical device software to account for this high risk potential.

The majority of software recalls in the 1990s were due to software defects that were a result of software being upgraded.

There is a need to restructure medical device software development processes, and adopting IEC 62304 provides a standard for design that is accepted in the United States (US) and European Union (EU).

IEC 62304 is a risk-based approach to compliance that ensures the standards followed are appropriate for their potential assessed risk.

IEC 62304 is a lifecycle approach that defines the activities and tasks required to ensure software for medical devices will be safe and reliable.

Applying IEC 62304 will reduce your overall rate of software failure and improve your bottom line.

Why Should You Attend 

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

Webinar Takeaway

  • Providing safe and effective medical devices is in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use software.
  • This session will provide insight into the IEC 62304 standard as it is applied to medical device software.
  • You will learn how to apply this standard to your own work processes.
  • You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance.
  • Q&A

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

Who will Benefit

Professionals in the following industries may also benefit from the content:

  • Pharmaceutical
  • Medical Device
  • Biotechnology
  • Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)

Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Carolyn Troiano

Faculty Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.  She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

Choose a Pricing Option

$229

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$299

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$349

Live Webinar + Recording

You get one log-in for the live 90-minute webinar for one participant and Access to archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night.