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VP Genomic Research - genomic test development for molecular diagnostics

VP Genomic Research, Los Angeles CA VP Genomic Research needed to manage operational and logistical tasks of genomic test development to ensure efficient execution of studies for molecular diagnostic products within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations.  The candidate will be responsible for designing the test development process, directing […]

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Lab Apprentices - Building a Workforce in a Tight Labor Market

Lab Apprentices —Building a Workforce in a Tight Labor Market Lab Apprentices are now available for CLIA, CAP and 17025 labs in California. “We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent […]

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Clinical Planning Manager Job/Senior CTM, Large Pharmaceutical

Sr. Clinical Planning Manager Large Pharma Client Needs Your Clinical Trial Expertise! A Clinical Planning Manager, capable of handling 12 teams with 25 members each of both internal and external members, is urgently needed by our client. You will use your 8 + years of industry experience to proactively identify potential pitfalls and steer the team around them. […]

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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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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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Oh no, you got a 483 letter…..now what?

Oh no, you got a 483 letter…..now what? ASQ Orange Empire Monthly Dinner Meeting – October 14, 2014

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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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ASQ Orange Empire Monthly Dinner Meeting - September 9, 2014

ASQ Orange Empire Monthly Dinner Meeting – September 9, 2014 WHEN Tuesday, September 9, 2014 5:15 PM – 9:00 PM Pacific Time

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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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Process Validation: Proactive and Robust Validation Programs

Process Validation: Proactive and Robust Validation Programs ASQ Orange Empire Monthly Dinner Meeting – August 12, 2014

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ASQ Orange Empire Monthly Dinner Meeting - May 13, 2014

ASQ Orange Empire Monthly Dinner Meeting Tuesday, May 13, 2014 5:15 PM – 9:00 PM Pacific Time

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Discover the Secrets of Preparing Written Procedures that Work

Discover the Secrets of Preparing Written Procedures that Work ASQ Orange Empire Monthly Dinner Meeting – March 11, 2014

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Success in Data Acquisition

Success in Data Acquisition   ASQ Orange Empire Monthly Dinner Meeting – March 11, 2014

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ASQ HDL Webinar: Facts Tell and Stories Sell

ASQ HDL Webinar: Facts Tell and Stories Sell Webinar on February 26

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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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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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Successfully Build Productive Teams

Successfully Build Productive Teams    Manage Personalities While Navigating Workplace Politics Join us for an ASQ HD&L Hosted Webinar on Tuesday, August 13 4:00pm-5:00pm PST Space is limited. Reserve your Webinar seat now at: https://www4.gotomeeting.com/register/836839199 Whether you are building a new team, or simply adding new members to an already existing team, choosing the right […]

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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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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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DMAIC Dissected

DMAIC Dissected : C – Control and New Revision of EU Restriction of Hazardous Substances (RoHS) ASQ Orange Empire Monthly Dinner Meeting – April 9, 2013 This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and […]

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DMAIC Dissected: A-Analyze and The 8D Problem Solving Process

DMAIC Dissected: A-Analyze and The 8D Problem Solving Process ASQ Orange Empire Monthly Dinner Meeting – February 12, 2013 This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. […]

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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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Going Beyond Lean Six Sigma and the Balanced Scorecard

Going Beyond Lean Six Sigma and the Balanced Scorecard ASQ Orange Empire Monthly Dinner Meeting – January 8, 2013 This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. […]

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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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Voice of the Customer

Voice of the Customer   ASQ Orange Empire invites you to our Monthly Dinner Meeting – November 13, 2012 This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. […]

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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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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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