We understand what a challenging time this is for our membership. Concerns about health, work situations (too much, hazardous, too little), and the economy weigh heavy on people's minds. I just heard The Queen's address. HRH said she hopes "everyone will be able to take pride in how they responded to this challenge." We have seen amazing responses to address this sinister disease. Health care providers, clinical associates and regulatory professionals have all stepped forward to develop solutions in record time and in innovative ways. While we practice physical distancing, we remain engaged and pushing forward. Thank you for your efforts.
Inspections Webinar Series, including Manufacturing, Laboratory, and Quality Systems, presented by Peter Baker, Green Mountain Quality Assurance, LLC
May/June 2020 Webinars with Peter Baker.
Register at https://greenmountainqa.com/webinars
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.
Questions?
For answers to frequently asked questions, please visit our FAQ page.