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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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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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NDA Submission Planning & Management

NDA Submission Planning & Management from the Medical Writer’s Perspective The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and […]

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Lean Six Sigma Principles Applied to Health Care

Lean Six Sigma Principles Applied to Health Care Presented by Michelle Kimbro, MBA, MBB THIS Wednesday,  10/15/14 @ 6::00 PM.        Biosense Webster 15715 Arrow Highway, Irwindale, Ca   6 – 6:30 pm – Registration, Networking and Dinner 6:30 – pm – Welcome, Announcements and Introductions 6:45 pm – Speaker 8:15 pm – Q & […]

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ASQ March 2014 Roundtable: Risk Based Environmental Monitoring

ASQ March 2014 Roundtable – Risk Based Environmental Monitoring (EM) This message is sent by the Southern California Discussion Group of the Biomedical Division of ASQ of the American Society for Quality as a benefit of your membership. ____________________________________________________________________ The Southern California Discussion Group of the ASQ Biomedical Division Presents: Risk Based Environmental Monitoring (EM)   How to […]

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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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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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Data Visualization

Data Visualization   Wednesday, July 17, 2013 at 6:30 PM Data Visualization By: Michael Scofield Asst. Professor, Health Information Management Loma Linda University Decision-makers often ask for “data”, but what they really want is information which will help them understand a problem or a condition around the decisions they need to make.  Yet they often do not know what […]

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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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Continuous Improvement and Process Variations

Continuous Improvement and Process Variations  WEDNESDAY  April 17, 2013   6 – 9 pm   ASQ 702 San Gabriel Valley Presents   Continuous Improvement and Process Variations Presented by Tarek Elneil Any manufacturing process has five components sequentially connected in the following order: Supplier, Input, Process, Output, and Customer; in short, called SIPOC. Each component of […]

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Delivering breakthrough product & process performance

Delivering breakthrough product & process performance The Southern California Discussion Group of the ASQBiomedical Division Presents:        Design of Experiment: Delivering breakthrough product & process performance            An Industry Roundtable Discussion                          

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Delivering breakthrough product & process performance

Delivering breakthrough product & process performance The Southern California Discussion Group of the ASQ Biomedical Division Presents:        Design of Experiment: Delivering breakthrough product & process performance            An Industry Roundtable Discussion                           Thursday, March 21, 2013 5:30pm to 8:30pm       Topic:    Utilizing a key six […]

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PMBOK vs Six Sigma: Using their Body of Knowledge

PMBOK vs Six Sigma: Using their Body of Knowledge   Our Next Monthly ASQ 711 Seminar will be held on February 20, 2013 6:30 PM PMBOK vs Six Sigma Using their Body of Knowledge Similarities Advantageously By: Bill Trappan  The two processes have many similarities and both are operated in accordance with detailed Bodies of […]

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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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Technical and scientific skills aren't enough

Technical and scientific skills aren’t enough in today’s workforce   Show Your Softer Side by Rosemarie Christopher As a whole, most experienced professionals value their technical mastery highly, and rightfully so. After all, look at the marvel of scientific achievement that is Curiosity, the robot the NASA Jet Propulsion Laboratory just put on Mars. Currently, […]

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SOCRA 21st Annual Conference September 21-23, 2012

SOCRA 21st Annual Conference September 21-23, 2012   Please join Rosemarie Christopher at the Society of Clinical Research Associates (SOCRA) 21st Annual Conference at the RIO All Suite Hotel in Las Vegas on September 21-23, 2012! Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be […]

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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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