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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073

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Free QServe Webinar - 10 Facts You Need to Know Now to Prepare for the IVDR
This 1-hour webinar will provide the answers to the pressing questions Senior Level Executives are asking as IVD manufacturers are preparing for the next major impact to EU Regulation and how this will affect the entire industry in 2022.

With the IVDR drawing near, Sue Spencer will cover the 10 KEY facts that executives need to know now and how it will affect your entire organization. The introduction of the IVDR is described as a cultural shift because it impacts so many parts of the business. If you think this only impacts quality and regulatory you need to listen to this webinar! Being prepared early could save you a lot of resources and money and the presentation will answer some very tough questions.

Register here.




New Medical Device Regulatory Intelligence Service from Emergo

The Regulatory Affairs Management Suite (RAMS) digital platform for global market access enables manufacturers to manage their device registrations and certifications across multiple countries and gain valuable market insights from a single, fully automated system. The software includes new tools and capabilities to support streamlined RA/QA operations.

 

Key capabilities include:

·         Registration Tracker and Regulatory Updates

·         Regulatory Overview Reports for 22 Markets

·         All of Emergo’s Regulatory Process Charts

·         Copies of global regulations already in Emergo’s website, plus expanded list of regulations and added markets

·         FDA 510(k) review time calculator and classification support, which extracts real-time information through connection with the FDA’s website

·         Regulatory FAQs to answer common and not so common questions and issues

 

Note: To Activate all features, make sure to enable them after signup by visiting the RAMS Marketplace. For questions, contact bdwest@ul.com.



JOB SHADOWING PROGRAM

Do you think you would like to share a day with a regulatory student, showing them how you do your job? 

Do you want to show a student ways to think through challenges, adapt to the new ISO rules, understand different country regulatory changes, or understand new biologics as examples. 

We are actively reaching out to match the newest members of our profession at the University of Washington’s BRAMS program with host ORCA members. Spend a day together.

This is an opportunity available to current members only.

Please contact Elizabeth Cross Nichol for more information or click on the buttons below to fill out an information or application form.

Host Information Form

Observer Application Form



ORCA NEEDS YOUR HELP!

Volunteers are vital to ORCA’s success. Volunteers assist ORCA with its monthly programs, plan those programs and solicit speakers, develop and implement marketing efforts and membership drives, serve on its Board of Directors, and provide a wide range of volunteer services that help make ORCA a meaningful and useful resource for its members. Visit our Volunteering page to find out more about how you can help.


The FDA and Prescription Drugs: Current Controversies in Context
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing and testing.


New Device Advice e-Learning Tool
The Medical Devices Bureau has announced the launch of a new Device Advice: e-Learning tool “Understanding How Medical Devices are Regulated in Canada – Premarket Regulations”. This learning module is intended to help stakeholders better understand what the premarket regulatory requirements are for the importation or sale of medical devices in Canada. 

 


LifeScience Washington Programs
Click here for more info on LifeScience Washington programs and events




FAQ

 

Forgot your login information?

No problem! Simply click on the ""Forgot Username/Password"" link located under the login window. If you are still having issues, visit our FAQ page for further instructions on how to retrieve your username and password as well as instructions on how to use other popular features on our website.


How do I renew my expired membership? 

Once you type your username and password and click ENTER, the system will prompt you to renew your membership before it gives you access to any of the Members Only menu options. For step by step instructions with screenshots, please visit our FAQ page.


Not receiving important ORCA emails?
ORCA uses a bulk email system to send meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance. If you have unsubscribed from receiving emails from our system, you will not receive any of these emails. 
To find out how to subscribe again, please visit our FAQ page.


Don't remember if you have already registered for a meeting?

Registered attendees can confirm their registration status by checking their Inbox for an Event Registration Confirmation email or by checking their Event History page under their member profile in the ORCA website. Make sure ORCA emails are not going to your Spam or Junk folder. Visit our FAQ page for more information.


Not listed in our Membership Directory?
As per our Terms of Use, some personal contact information of members will be included in the ORCA Member Directory that is made available to each ORCA member unless a member explicitly declines to be included. When you join ORCA, the default Member Directory selection is for some of your contact information to be listed. If you inadvertently changed this option and are no longer listed in our Member Directory, follow the instructions provided in the FAQ page under Membership - How do I update my directory listing selection? to select which information you would like to be listed in our directory.
To opt out of the Member Directory, please follow the FAQ instructions under Membership - How do I opt out of the online Member Directory? .


For more answers to frequently asked questions, please visit our FAQ page.



Knowledge Center

Useful FDA educational resources


CDRH Learn

FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education

https://www.fda.gov/training-and-continuing-education/cdrh-learn

 

CDRH Medical Device Webinars and Stakeholder Calls

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-an

 

CDER Learn

The web page for educational tutorials offered by the Center for Drug Evaluation and Research

https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education

 

CDER Meetings, Conferences, & Workshops

https://www.fda.gov/drugs/news-events-human-drugs/meetings-conferences-workshops-drugs

 

CBER Sponsored Workshops, Meetings & Conferences

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-bi

 

OTAT Learn

The Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education.

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn


The Robert J. Margolis, M.D. Center for Health Policy
Calendar of Events