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Partners/Other Organizations

OCRA has several special interest groups that focus on issues germane to regulatory affairs professionals. Take advantage of these SIGs that give you the chance to meet and discuss relevant topics with your peers.  Meetings of these specialty groups are free to OCRA members!

CMC Discussion Group

The CMC Discussion Group formally came into being with the launch of the first meeting in February 2013.  This SIG focuses on pertinent regulatory, quality, and compliance issues related to Chemistry, Manufacturing, and Controls in the areas of drugs, biologics, diagnostics, and supplements.  The group provides a forum for peer-led discussions on selected topics and allows attendees to exchange ideas, experiences, and best practices.  

As a result of geographical challenges, meetings of the CMC Discussion Group may be held jointly in person and virtually.  We work with local companies that volunteer their virtual meeting capabilities to facilitate access to members throughout Southern California. Please contact us if you would like to volunteer speakers, topics, or technology.

Please keep an eye on the OCRA Events Calendar for the next gathering of the CMC Discussion Group. We hope to see you there!

CMC Discussion Group Chair: Ruchika Raval

Device Alliance

Device Alliance Logo
 
DeviceAlliance is a community of talented and successful medical device professionals. We offer multiple ways to get engaged: 
 
Networking Programs
There’s no better opportunity to connect with the industry’s best and brightest than at our networking events.
• Social events provide casual environments for connecting, networking and having collegial discussions on topics affecting virtually all medical device enterprises
• These forums are typically where career and entrepreneurial opportunities first arise
• Mentorship for young professionals seeking career support and development
• ‘Shout-Outs’ offer an opportunity at our social events to acknowledge those who embrace the spirit of paying-it-forward by sharing their insight and expertise with other members

Mastermind Programs
• Mastermind Panels are interactive forums that benefit each of our members and focus on critical topics which impact medical device executives and the companies that employ them
• Mastermind Focus Groups provide an opportunity for our sponsors to brainstorm with the smartest professionals in the industry

Educational Programs
DeviceAlliance members are passionate about life-long learning; this is why we produce special events which focus on emerging trends in our industry. For example:
• Exploration of where the medical device and the consumer world are joining
• Wearable Technologies: The Present and the Future

Collaboration
Collaboration among members is an outcome of our willingness to serve each other. Living this core value builds trust among our members and trust leads to collaboration.
Our members are creative professionals who can work with you ‘on your business,’ or ‘in your business’
Mentorship
Benjamin Franklin was an inventor and a visionary. Plus, he knew how to have fun. We like to quote Ben when we think of virtues of mentoring:

“Tell me and I forget, teach me and I may remember, involve me and I learn.”
 

MDR Network Group

The MDR Network Group was started in May 1996. The goals of the group are to:

  1. Understand the FDA MDR reporting requirements (21 CFR 803)
  2. Share best practices of implementing the MDR regulations
  3. Obtain a perspective of adverse event and product problem reporting from the user facility perspective
  4. Understand the international reporting requirements for medical device adverse events
  5. Understand common pitfalls and mistakes made by manufacturers
  6. Network with other professionals who work specifically in the complaint, MDR, and international reporting areas

The MDR Network Group has also worked with the FDA to establish a two-way communication on MDR issues. The MDR Network Group received the Vice-Presidential Hammer Award from Al Gore in May 1999 for their partnership with the FDA towards reaching their common goal of patient safety.

Please check the OCRA Events Calendar for the next MDR Network Group meeting. If you would like to suggest a new topic, or would like to speak to the group on a particular subject, please contact Chris Posin at This email address is being protected from spambots. You need JavaScript enabled to view it..