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April 8, 2015

Risk Based Auditing Fundamentals

Risk Based Auditing Fundamentals You are Invited to an Evening Meeting Risk Based Auditing Fundamentals Orange County Regulatory Affairs Discussion Group Tuesday, April 21, 2015 4:00 – 7:00 pm

October 17, 2014

Regulatory Inspections and How to Manage Them

Regulatory Inspections and How to Manage Them You are Invited to an Evening Meeting Regulatory Inspections and How to Manage Them Orange County Regulatory Affairs Discussion Group (OCRA) Wednesday, November 5, 2014 5:30 – 9:00 pm

October 17, 2014

Precision Medicine: A Medical Miracle or Ethical Nightmare?

Precision Medicine: A Medical Miracle or Ethical Nightmare? The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician […]

August 18, 2014

Secrets to Success: Pre-Subs, 510(k)s, and FDB

Secrets to Success: Pre-Subs, 510(k)s, and FDB Wednesday, September 10, 2014

August 18, 2014

Is it a Recall? Now what do we do?

Is it a Recall? Now what do we do? Thursday, August 28, 2014 Noon – 5:30 pm

October 16, 2013

Risk Management

Risk Management Orange County Regulatory Affairs Discussion Group Thursday, November 14, 2013 Location: Irvine Marriott 18000 Von Karman Irvine, CA 92612 949-553-0100

October 10, 2013

Clinical Trials 101

Clinical Trials 101 Joint Meeting with San Diego Regulatory Affairs Network (SDRAN) and Orange County Regulatory Affairs Discussion Group Wednesday, October 30, 2013

September 16, 2013

CRITICAL PROJECT EXECUTION

CRITICAL PROJECT EXECUTION: The Keys to Success Wednesday, September 25th, 2013 from 5:30 PM to 8:30 PM (PDT) Biosense Webster 15715 Arrow Highway, Irwindale, CA

May 15, 2013

Manager of Regulatory Affairs, Orange County CA

Manager of Regulatory Affairs, Orange County CA Job Description • Manage Regulatory Affairs activities to include, but not limited to: o Canadian Regulatory Submissions o International Regulatory Submissions Teams o Emerging Market Regulatory Strategy o Global Product Assessments and Approvals o Product Development Teams o Regulatory Guidance for  Change Control  Product Review Boards […]

May 15, 2013

Director of Regulatory Affairs, Orange County CA

Director of Regulatory Affairs, Orange County CA Job Description • Direct Regulatory Affairs activities to include, but not limited to: o Domestic and Global Regulatory Intelligence o Regulatory Strategy o Regulatory Communication o Global

May 15, 2013

Sr. Manager/Director of Medical Education – Orange County, CA

Sr. Manager/Director of Medical Education – Orange County, CA As part of Global Medical Affairs, the Sr. Manager/Director of Medical Education is responsible for the successful execution of company Medical Affairs programs, including: • Plan, manage and execute company’s New Customer Training and certification program worldwide, implement Staff and Surgeon training modules, develop strategies for […]

May 7, 2013

"Be in the know!"

“Be in the know!” Check out MEIRxRS’ new “quick read newspaper” and be in the know about what’s new in clinical research, regulatory affairs, quality assurance and medical affairs.

April 11, 2013

2013 Workshop - Marketing of FDA Regulated Products

2013 Workshop – Marketing of FDA Regulated Products FDA Centers, FDA Los Angeles District Office and the Orange County Regulatory Affairs Discussion Group Present The 16th Annual FDA-OCRA Educational Conference June 12-13, 2013 Irvine Marriott 18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100 The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and […]

April 2, 2013

Building and Maintaining Quality in Clinical Trial Performance

Building and Maintaining Quality in Clinical Trial Performance FDA Inspections of Clinical Research Sites and Sponsors Building and Maintaining Quality in Clinical Trial Performance Wednesday, April 10, 2013 5:30 – 8:30 pm Location: AMO Headquarters 1700 East St. Andrews Place Santa Ana, CA 92705-4933 Program Managers: Terrie Hopton, Manager, Business Development and Special Projects, Promedica International […]

January 28, 2013

Drug Shortages from the FDA, Industry, and Consumer Perspectives

Drug Shortages from the FDA, Industry, and Consumer Perspectives Orange County Regulatory Affairs Discussion Group (OCRA) Friday, February 22, 2013 8:00 am to Noon Free of Charge OCRA Membership is Required (Employees of Host Locations do not need to be Members) Four Locations To Choose From: Amgen One Amgen Center Drive; Thousand Oaks, CA 91320 Beckman […]

January 3, 2013

OCRA Supplements Update: What's on the Horizon in 2013

OCRA Supplements Update: What’s on the Horizon in 2013 Orange County Regulatory Affairs Discussion Group (OCRA) Wednesday, January 9, 2013 12:30 pm – 5:00 pm Location: Irvine Marriott 18000 Von Karman, Irvine, CA 92612 949-553-0100 Program Managers: Rogelio Rodriquez Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and Intellectual Property, […]

October 16, 2012

The Difference Between Success and Failure in the Medical Device

The Difference Between Success and Failure in the Medical Device Business Selecting Alternative Regulatory Pathways to Market Orange County Regulatory Affairs Discussion Group You are Invited to an Evening Meeting The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market Wednesday, Oct. 24, 2012 Time: 6:00 pm – 8:00 pm […]

October 15, 2012

Medical Device Reporting Inspections and Exemptions

Medical Device Reporting Event: Inspections and Exemptions Orange County Regulatory Affairs Discussion Group (OCRA) Wednesday, November 7, 2012 3:00 – 7:00 pm Location: Irvine Marriott 18000 Von Karman, Irvine, CA 92612 949-553-0100

August 30, 2012

Your Products and the Environment

Your Products and the Environment: Responsibilities & Stewardship Sept. 12, 2012 5:00 pm – 8:00 pm Beckman Coulter, Inc. 250 S. Kraemer Blvd. Training Center, Building #A (entrance is off of Kraemer Blvd.) Brea, CA 92822 Session Speakers: Eri Hirumi, Group Manager of Corporate Regulatory Affairs, Beckman Coulter Neal Langerman, PhD, Founder, Advanced Chemical Safety, […]

August 23, 2012

How To Get It Right The First Time

How To Get It Right The First Time ASQ FDC SCDG Presents… How To Get It Right The First Time Thursday, August 23, 2012 5:30 p.m. – 8:30 p.m. Baxter BioScience 1 Baxter Way #100, Thousand Oaks, CA 91362 Speaker & Host: Mary Thorsness, Quality Manager – CAPA Division, Baxter BioScience Mary graduated with a bachelor’s […]