MEIRxRS Blog and News

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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

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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 

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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 […]

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

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

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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  

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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  

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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  

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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

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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 […]

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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

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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 […]

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"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.

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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 […]

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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 […]

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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 […]

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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, […]

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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   […]

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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  

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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 […]

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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 […]

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