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A non-profit volunteer organization comprised of Regulatory Affairs professionals, OCRA has over 700 members representing more than 225 companies in Orange County and surrounding areas.

Tuesday, December 06, 2016

Networking / Special Interest Groups

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

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..

TUV SUD America

Apr 21, 2016 1454
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Contact: Dr. Royth von Hahn Specialty: Devices, IVD

Enterey, Inc.

Apr 21, 2016 2086
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Contact: Tita Tavares, Business Development Manager Specialty: Biologics/Biotechnology,…

Strategic Regulatory Solutions, Inc.

Apr 13, 2012 15014
Contact: Gustavo Kobrin, PresidentSpecialty: Devices

Consultant Directory

Jan 23, 2016 3707
This directory supplies information about consultants providing regulatory, clinical, and…

Arivis

Jun 02, 2015 1564
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Contact: Adair Turner, MS, RAC, Director of Regulatory and Clinical Operations…

A Regulatory Consultants Group (RGC)

Mar 31, 2016 2266
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Contact: Trudy R. Papson Specialty: Auditing, Gap Analysis, Mock FDA Inspections for…

Kim Walker Consulting

Apr 28, 2014 1293
Contact: Kim Walker, MS, RAC (US & EU) Specialty: Devices, IVD, New Drugs/OTC,…

Greg Godfrey & Associates

Feb 03, 2011 2512
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Contact: Greg Godfrey, RAC, CQE, CQA - Owner & Principal Consultant Specialty: Devices

Noblitt & Rueland

May 09, 2009 4321
Contact: Brent Noblitt, Senior PartnerSpecialty: Devices, IVDs, Biologics/Biotechnology

Promenade Software, Inc.

Aug 26, 2016 753
Contact: Frances Cohen, President Specialty: Devices, IVD

Quintiles Consulting

Jun 01, 2015 4996
Contact: Phil Johnson, Senior Director, Quality & Compliance Services Specialty: New and…