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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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Defining Quality

Defining Quality “There is still no official definition of quality that serves all purposes.” ASQ Quality Progress Magazine August 2013

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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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Top 5 Retention "Carrots" (Rewards)

Top 5 Retention “Carrots” (Rewards)   Top five “carrots” to entice employees to stay with a company, according to Career Builder’s nationwide survey of hiring managers, HR professionals and workers: Salary increase 70% Better benefits 58% Flexible schedule 51% Employee recognition 50% Ask for employee feedback and put into action 48%

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Quality Cross Roads

Quality Cross Roads WEDNESDAY  May 22, 2013    6 – 9 pm ASQ 702 San Gabriel Valley Presents   Quality Cross Roads Presented by Mike Hoss  For many years quality professionals across all line of businesses have struggled with cross roads. Value adds vs. compliance, prevention vs. detection, operation’s role vs. quality professional’s role, Cost of […]

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The Balanced Scorecard: What is it? Who needs it?

The Balanced Scorecard: What is it? Who needs it? Abstract: The Balanced Scorecard was originated by Drs. Robert Kaplan and David Norton who describe it as follows * “The balanced scorecard retains traditional financial measures. But financial measures tell the story of past events, an adequate story for industrial age companies for which investments in long-term capabilities and customer relationships […]

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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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Analysis of the NASA/JPL ePrognostic Algorithm

Analysis of the NASA/JPL ePrognostic Algorithm using Modeling and Simulation Techniques with Design of Experiment (DOE) Methods Tuesday, May 14, 2013 from 6:00 PM – 9:00 PM Courtyard Marriott Oxnard  | 600 E Esplanade Dr | Oxnard, CA 93036 Analysis of the NASA/JPL ePrognostic Algorithmusing Modeling and Simulation Techniques with Design of Experiment (DOE) Methods Presenter:  Dr. Kitt C. Carlton-Wippern (ret.) Naval Sea Systems […]

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2013 Women in Science and Technology Conference

2013 Women in Science and Technology Conference Aspire, Attain, Ascend Successfully Build Productive Teams: Manage Personalities While Navigating Workplace Politics Presented by Rosemarie Christopher, President & CEO of MEIRxRS UCSD Faculty Club 9500 Gilman Drive La Jolla, CA 92093 Saturday, May 18, 2013 4:00 pm – 5:00 pm Register for the conference by May 14th at ~closed~. […]

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Project Monitoring and Controlling

Project Monitoring and Controlling How Do You Know the Status of Your Project? Project Monitoring and Controlling Topics to be presented: The amount of information generated during project execution can be overwhelming. How do you make sense of it all? How do you determine when to make corrective changes? This presentation discusses ways to improve […]

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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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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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Earn what you are worth in three steps

Earn what you are worth in three steps Show your boss that you are worth it! Does your boss see intangible advances in paying you more? Do you have influence? A personal brand that gives you an added value to the company?  Know your worth and value in the marketplace. Find out what your services […]

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Get Hired and Stay Employed in a Multi-Generation Workforce

Get Hired and Stay Employed in a Multi-Generation Workforce Career Workshop & Mock Interview Session Getting Hired and Staying Employed in a Multi-Generation Workforce Presented by Rosemarie Christopher, President/CEO of MEIRxRS   Are you ready? Can you earn top dollar? Can you showcase your skills? Can you communicate your worth? The workshop is an interactive session […]

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The 12th SABPA Education and Career Development Event

The 12th SABPA Education and Career Development Event  When:  11:30 am to 2:00 pm, Saturday, April 6, 2013 Where: TBD Registration: https://www.123signup.com/register?id=bcbsk $10 ($5 student) until April 1st online; $20 onsite ($10 student onsite) Weblink: http://www.sabpa.org/web/news_details.php?ID=457   Summary: Dr. Yuan Xu (VP, Novartis) and Mr. Brian O’Callaghan (CEO, Sangart) will discuss their career paths, views […]

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Video Mapping

Video Mapping Our Next Monthly ASQ 711 Seminar will be held on March 20, 2013 6:30 PM Video Mapping By: Kenneth Nguyen Abstract: Video mapping captures a process through a camcorder at the site of occurrence and allows a team to view the process as though they are at the site themselves. This process allows […]

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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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Certified Quality Auditor - Prep/Refresher Course

Certified Quality Auditor – Prep/Refresher Course Summary  http://www.cvent.com/events/certified-quality-auditor-prep-refresher-course/invitation-10c825d1d2394faaaed4f0b0be773af6.aspx?i=54329969-5fc8-405a-8568-253be1a1af83 Exam Date June 1, 2013 Exam Application Deadline April 12, 2013 Sessions / Dates 9 sessions; Mondays from April 1, 2013 to May 27, 2013. Will cover: Certification Overview, Auditing Fundamentals, Auditor Competencies, Audit Preparation, Audit Performance, Audit Reporting, Audit Follow-up & Closure, Audit Business Applications, Quality Tools & […]

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Creating Performance Metrics that will Drive Results

Creating Performance Metrics that will Drive Results Performance Metrics Convert Information into Results! An Industry Roundtable Discussion  Wednesday, March 20, 2013     6:00pm to 9:00pm Topic: Creating Performance Metrics that will Drive Results   Quality performance metrics visually represent relevant data and provide a means by which to convert information into results.  Diane Kulisek will provide […]

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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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Critical Regulatory and FDA Compliance Issues

Critical Regulatory and Compliance Issues with the US FDA in the 21st Century   Spring AOAC SCS – USP WCDG Joint Conference – “Critical Regulatory and Compliance Issues with the US FDA in the 21st Century”   When:  7:00 am to 4:00 pm, Thursday, March 7 & Friday, March 8, 2013  Where: US FDA facility […]

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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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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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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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A Deeper Look at Deming's System of Profound Knowledge

A Deeper Look at Deming’s System of Profound Knowledge ASQ Orange Empire presents…A Deeper Look at Deming’s System of Profound Knowledge WHERE Brandman University 16355 Laguna Canyon Road, Room #111, Irvine, California 92618 USA WHEN March 1, 2013 8:00 AM -4:00 PM ATTIRE Business Attire FEES ASQ Section 701 Member: $130, if registered by February […]

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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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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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ASQ HD&L - Future of Lean Technology

ASQ HD&L – Future of Lean Technology & Impact on Leaders / Economy Title: ASQ HD&L – Future of Lean Technology & Impact on Leaders/Economy Date: Wednesday, January 23, 2013 Time: 6:00 PM – 7:00 PM CST Space is limited. Reserve your Webinar seat now at https://www1.gotomeeting.com/register/768787800 In this presentation Dr. Allen will show how the […]

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Data Analysis: Making the right decision & proving it!

Data Analysis: Making the right decision & proving it! The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 Presents: Data Analysis: Making the right decision & proving it! An Industry Roundtable Discussion Tuesday, Jan 15, 2013 5:30pm to 8:30pm Topic: Assessing data, making decisions, & presenting the evidence […]

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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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Discover Your "WHY"

Discover Your “WHY” Topic: Discover Your “WHY” Presented by: Frumi Barr, PhD December 11 – December Social Dinner Meeting Our Section’s December program is designed for the entire family. Having a purpose is critical to happiness, passion, and achieving dreams. Do you understand your “Why?” Let Dr. Frumi Barr introduce you to your “WHY.” Bring […]

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The 5 Success Habits of High Performance Teams

The 5 Success Habits of High Performance Teams December 7, 2012 – Educational Seminar Topic: The 5 Success Habits of High Performance Teams Full Day Seminar Presenter: Chris Alexander There is no difference between a high-performance business team and a team of Olympic athletes. In business as with world-class sports teams, teamwork is a competitive advantage. The […]

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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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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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Change-Is It Always Good?

Change-Is It Always Good? ASQ Section 711 presents… Change-is it always good? A non-political seminar by Jeff Croddy Change. Why does everything have to change? Everything ran so well, then bang!, some new idea comes down from the boss. Sound familiar? Change is the ever-present vehicle that is both heralded and blamed for successes and […]

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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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Quality in Performance Management

Quality in Performance Management Today’s economic climate and competitive marketplace demand peak performance from everyone involved, and each individual, from the mail room to the CEO,  has the ability to affect change and drive business results. Join Gary Urban, Executive Director of Operations at Rx Research Services Clinical Research Organization (RxRS CRO) and explore his […]

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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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Quality Basics: Cost of Quality

Quality Basics: Cost of Quality ASQ Section 711 Inland Empire presents… Cost of Quality (COQ) by Duane Allen October 17, 2012 at 6:30pm Home Town Buffet: 390 McKinley Avenue, Corona Hills Plaza, Corona Hills, CA 92879 Cost: $12.50 per person Reservation not required. Guests are always welcome.   Cost of Quality (COQ) is a basic tool for […]

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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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5S - reduce waste and improve your efficiency

5S – reduce waste and improve your efficiency The 5S philosophy focuses on effective workplace organization and standardize work procedures. A robust 5S program will reduce waste and improve your efficiency while improving quality and employee safety. 5S is based on Japanese words that begin with the letter “S.” The term 5S references the five […]

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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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Use Data to Drive Continuous Improvement

Use Data to Drive Continuous Improvement Wednesday, September 19, 2012 5:30 PM to 8:30 PM Gilead Sciences 650 Cliffside Dr San Dimas, CA 91773 Register now! For the manufacturers to deliver a high quality product with low cost they must have an effective Continuous Improvement program. Continuous Improvement objective is to reduce the process variation. […]

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