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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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Reproducibility Crisis in Biomedical Research

The Reproducibility Crisis in Biomedical Research New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research! “The productivity of modern drug development has been steadily



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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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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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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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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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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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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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Innovations in Biologics Discovery and Development

Innovations in Biologics Discovery and Development   SABPA Science & Technology Forum – Innovations in Biologics Discovery and Development (March 23, 2013)   Innovations in Biologics Discovery and Development   Date:                March 23, 2013, Saturday, 8:30am to 1:00pm (Breakfast and lunch will be provided) Location:         Institute of Americas, UCSD, (Direction available at http://www.sabpa.org/web/news_details.php?ID=449) […]



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Current Trends in Good Manufacturing Practice

Current Trends in Good Manufacturing Practice ASQ Orange Empire Presents…. Current Trends in Good Manufacturing Practice This workshop is designed for anyone working in the FDA regulated industries and requires a comprehensive understanding of the basic concepts of Good Manufacturing Practice. FDA regulated industries includes pharmaceuticals, medical devices, blood products, biologics, dietary supplements, cosmetics, and foods. Some […]



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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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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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