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Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?

6.0
RAC Credits
Thursday, 17 September 2020 (9:00 AM) - Thursday, 17 September 2020 (2:00 PM) Eastern Time (US & Canada)

Often regulatory professionals are responsible for ensuring all human factors requirements for regulatory submissions are met, even though they may be unfamiliar with the subject. With increasing complexity in the global regulatory landscape and related human factors requirements, regulatory professionals need specific knowledge about human factors to prevent this key requirement from derailing regulatory submissions or causing unnecessary post-submission delays, such as additional studies or other regulatory requirements. This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.


Pricing Amounts & Deadlines 

6/23/2020 -8/14/2020:  Early Bird $400.00 Member | $500.00 Nonmember

8/15/2020 – 9/14/2020:    Regular $500.00 Member  | $600.00 Nonmember


Objectives

  • Overview of regulatory requirements relating to human factors including introduction to key human factors standards and guidance
  • Defining what human factors is (and is not) and general requirements of human factors submissions
  • Purpose and benefits of different types of human factors studies related to regulatory submissions
  • Planning considerations for human factors activities
  • Planning for and conducting successful regulatory authority interactions
  • Monitor product development and human factors timeline and activities to identify impacts to the regulatory submission timeline
  • Determining preparedness for HF validation
  • What a successful human factors validation looks like (and when a validation becomes an unexpected formative)
  • Determining and presenting residual risk post-validation
  • Strategies for using human factors data to support design decisions and provide rationale to regulatory authorities as part of regulatory interactions or submissions


Click here to download the agenda


Speakers




RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.

Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.


Program Contact

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA