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Apprentices Available

Apprentices Available Apprentices available to build a fresh new pool of talent in Quality, Regulatory, Clinical and Medical roles for Food, Biotech, Pharmaceutical and Medical Devices. Our grants cover part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years.  We currently have two

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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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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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Knowing the best practices in applied statistics

Knowing the best practices in applied statistics uesday, March 11, 2014     5:30pm to 8:30pm The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 presents:

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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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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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Quality Management Systems

Quality Management Systems presented by Marianne Silva This meeting is appropriate for those people in the medical products, clinical laboratory and food products industries who are currently developing or wish to improve the compliance or effectiveness of their company’s Quality Management System. REGISTER HERE The presentation on August 20th will provide: An introduction to Quality Management […]

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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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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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Introduction to Minitab

Introduction to Minitab   ASQ 702 is Proud to Present “An Intro to Minitab” Date: Saturday, March 9th Time: 8:00am – 1 pm Location: Biosense Webster 15715 Arrow Hwy., Irwindale, Ca 91706 Are you new to Minitab, or perhaps just need a little help in maneuvering thru the menus? Want to learn more of the […]

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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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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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The Supplier Did What?!

The Supplier Did What?!   All too often we realize (a bit too late) that for some reason suppliers have an impact on our products and services. As it turns out, ensuring the consistent supply of “good” parts and services is key to any business. But what should we do? And how far do we […]

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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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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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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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