Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Across all sectors of the economy – Risk Management continues to assume increasing importance. However, much remains to be done to understand the concepts of quantifying, analyzing, and addressing risk. This is seen because the same kinds of risks (due to adverse events) surface repeatedly. Numerous cases bear this out – from recurrent risks of cancers to administering wrong medications, implants, surgery, and labeling errors.
Several attempts have been made via embedding risk management (or taking a risk-based approach) in various standards such as ISO 13485 for medical devices, guidelines for adopting a risk-based approach by the FDA, and the European Medicines Agency (via ICH 10). None of these discuss, acknowledge, or refer to the cognitive human limitations of risk management. ISO 14971 touches on human behavior but only in the context of the user’s interaction with a medical device.
In this webinar, attendees will discover the latent human cognitive mistakes that impact how to meet or miss the requirements and guidelines particularly applicable to the life sciences industry. Many who have attended this online seminar commented it was an eye-opener for them – in more than one way.
A live Q&A with the speakers will follow the presentation.
This event is brought to you by the RAPS Utah Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Gain insight and prevent five cognitive errors that derail Risk Management efforts of life science companies in the following areas:
Intermediate
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.
RAPS Membership
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
Instructors:
Rai Chowdhary, CEO, The KPI System
Rai Chowdhary is the CEO of The KPI System. He has worked in the life sciences industry for more than 20 years, starting as an engineer and rising to executive ranks. Along the way, he has invented new products and technologies, led new product teams, launched corporate initiatives on Lean, and Six Sigma, and imbedded risk-based approaches in several firms. Chowdhary’s certifications include Lead QMS Auditor for ISO 9001, 13485, Software Security, Lean, Six Sigma, CQE, CQA, and CMQ/OE. He earned credentials in mechanical and manufacturing engineering from the University of Mumbai, and a master’s in materials science from Arizona State University.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Registration fees for this event are nonrefundable.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.