MEIRxRS Blog and News

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FSMA Compliance Workshop 2015

FSMA Compliance Workshop 2015   FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance. Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders […]

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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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2015 Southern California Food Industry Conference

2015 Southern California Food Industry Conference Button Up for the Winds of Change  Labels, Regulations, and Consumer Expectations   Wednesday March 4, 2015 9am – 3pm

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Outsourcing 101

Outsourcing 101    You are Invited to the Joint Fall Conference    Sponsored by San Diego Regulatory Affairs Network (SDRAN) and  Orange County Regulatory Affairs Discussion Group (OCRA)    Wednesday, November 19, 2014 

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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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Understanding How FDA Looks at Outsourcing

Understanding How FDA Looks at Outsourcing When:  Thursday, October 9, 2014 at 6:00 PM Where:  The Wyndham, 17941 Von Karman Ave., Irvine, CA 92614

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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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CAPA and Root Cause Analysis

CAPA and Root Cause Analysis Orange County Regulatory Affairs Discussion Group Wednesday, March 5, 2014 8:00 am – 5:00 pm

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MDR Network Meeting

MDR Network Meeting Orange County Regulatory Affairs Discussion Group Invites You To MDR Network Meeting Tuesday, December 3, 2013 4:00 – 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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Global Supplier Management

Global Supplier Management Evening Event Global Supplier Management: Share and Learn Best Practices From Industries with a Long-Standing History of Robust Supplier Quality Programs Orange County Regulatory Affairs Discussion Group Tuesday, September 17, 2013

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The Value of Good Science

The Value of Good Science Special Summer Event A Night at Discovery Science Center Orange County Regulatory Affairs Discussion Group Monday, August 19, 2013  Location:        Discovery Science Center

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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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Boost Your Brand

Boost Your Brand: Soft skills are vital in today’s workplace by Rosemarie Christopher In an era when many workplaces are in flux, it may seem like there is little opportunity to build your personal brand and influence organizational culture. I would argue there’s no better time to do so than when there is momentum 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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OCRA Member Appreciation Night

OCRA Member Appreciation Night   Orange County Regulatory Affairs Discussion GroupExhibit Show and Networking Event Featuring Wine and Cheese Pairings and Beer TastingAll OCRA Members Invited Free of Charge Wednesday June 12, 2013 5:00-8:00 pm  Please join us at Irvine Marriott In the Tuscany Ballroom and Tuscany Patio (indoor/outdoor event) 18000 Von Karman Avenue, Irvine, CA […]

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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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FDA, Regulatory and Compliance Update: 2012

FDA, Regulatory and Compliance Update: 2012   Wednesday, October 10, 2012 7:30 am – 4:00 pm Hologic Gen-Probe, Inc. 10210 Genetic Center Drive San Diego, CA 92121 Register Online This event is brought to you by the Orange County Regulatory Affairs Discussion Group (OCRA) and San Diego Regulatory Affairs Network (SDRAN).

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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 Safety, […]

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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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FDA: In God we trust

FDA: In God we trust, for everyone else, we require documentation   Date: Wednesday, August 22, 2012 Time: 4:30 pm-8:30 pm Location: 2525 Dupont Drive, Irvine, CA 92612 Registration: http://library.constantcontact.com/download/get/file/1101994467498-376/OCRA+8-22-12+Meeting+Flyer.pdf (pre-registration required, no walk ins allowed) Orange County Regulatory Affairs Discussion Group (OCRA) presents… Dangerous Documentation: Don’t Be Haunted By Your Words In 2011 over […]

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