eScope - ASQ Orange Empireasqorangeempire.org/wp-content/uploads/2016/01/2016-01-eScope.pdf ·...
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January 2016 eScope The official newsleƩer of the ASQ Orange Empire SecƟon 0701 Upcoming Events January 11, 2016 (NOTE: Monday!!) Monthly Dinner MeeƟng Inside this Issue Pg. SecƟon Chair Update 1 2016 Leadership Team 2 New Members 3 Monthly RecerƟfied Members 3 Volunteer OpportuniƟes 4 EducaƟon OpportuniƟes 5 “Leveraging Quality Tools Throughout the OrganizaƟon” 7 Monthly Dinner MeeƟng 10 Upcoming Conferences 12 SecƟon Chair Update Dear Quality Colleagues, I hope you had a great Holiday Season in company of your loved ones and that this new year brings you great things! With the start of a new year, a new chapter in our lives begins. Just like a blank piece of paper, the new year awaits for us to write our own chapter of accomplishments as well as failures. Both of them are im‐ portant in the cycle of life. To reach where we want to be, we must be bold, take chances and drive with the spirit to conquer our dreams. Don’t let obstacles stand in your way. Find their purpose and use them as stepping stones to get your where you want to be. Let’s make 2016, a chapter in our lives that fulfills our intellectual, physical and spiritual needs on our way to conquer our dreams. For those that I have not had the pleasure to meet, my name is Dieter Eckstein. I have been given the honor to be at your service as the Chair of our ASQ SecƟon 0701 for 2016. I have been serving our secƟon for a liƩle over 4 years, starƟng as the Historian/NewsleƩer Editor, and the last 2 years as the Vice‐Chair. Inspired by a great group of professionals that are pas‐ sionate about Quality and helping others with their professional careers, I decided to not complain and volunteer some of my Ɵme to join them in making a difference. Our Leadership CommiƩee and I discussed and approved a Business Plan for 2016 with objec‐ Ɵves that include membership growth, membership retenƟon, membership value, provide valuable cerƟficaƟon opportuniƟes, and provide resources to our local business communiƟes to name a few. We are aiming at giving YOU, our members, the best value for being part of our ASQ SecƟon. I am counƟng on our Leadership CommiƩee to engage with me the acƟons to be bold, take our chances and drive our secƟon to a beƩer place. However, we are only half of the success story, we sƟll need YOU to be there to take advantage of it all. I invite you to take advantage of the programs and resources that we will make available to you to further your careers. Make it a point to join us at our dinner meeƟngs, seminars, oth‐ er acƟviƟes and programs throughout the year. Don’t under‐esƟmate the importance of knowledge and networking opportuniƟes that our secƟon brings to you. There is always a new thought, a new angle, or a piece of the puzzle that you could be missing to take your career to the next level. Lastly, I want to thank Anet Ant for her contribuƟons as the Chair for our secƟon over the last couple of years. As one of youngest Leaders, she brought to our secƟon a very important infusion of youth that our secƟon needed to conƟnue being a benchmark ASQ group for gen‐ eraƟons to come. She has been a great ambassador for our secƟon at the World Conference for Quality and Improvement, Regional events and other acƟviƟes within our secƟon. I wish Anet the best in her future endeavors and I look forward to her future contribuƟons and achievements. May you, your families and friends be blessed with a great 2016! Dieter Eckstein, BSBM, ASQ CMQ/OE, CQA SecƟon Chair, ASQ Orange Empire 0701 Dieter Eckstein, BSBM, CMQ/OE, CQA - ASQ Orange Empire Section 0701 Chair
Transcript of eScope - ASQ Orange Empireasqorangeempire.org/wp-content/uploads/2016/01/2016-01-eScope.pdf ·...
January 2016
eScope The official newsle er of the ASQ Orange Empire Sec on 0701
Upcoming Events
January 11, 2016 (NOTE: Monday!!) Monthly Dinner Mee ng
Inside this Issue Pg.
Sec on Chair Update 1
2016 Leadership Team 2
New Members 3
Monthly Recer fied Members 3
Volunteer Opportuni es 4
Educa on Opportuni es 5
“Leveraging Quality Tools Throughout the Organiza on”
7
Monthly Dinner Mee ng 10
Upcoming Conferences 12
Sec on Chair Update
Dear Quality Colleagues,
I hope you had a great Holiday Season in company of your loved ones and that this new year brings you great things!
With the start of a new year, a new chapter in our lives begins. Just like a blank piece of paper, the new year awaits for us to write our own chapter of accomplishments as well as failures. Both of them are im‐portant in the cycle of life. To reach where we want to be, we must be bold, take chances and drive with the spirit to conquer our dreams. Don’t let obstacles stand in your way. Find their purpose and use them
as stepping stones to get your where you want to be. Let’s make 2016, a chapter in our lives that fulfills our intellectual, physical and spiritual needs on our way to conquer our dreams.
For those that I have not had the pleasure to meet, my name is Dieter Eckstein. I have been given the honor to be at your service as the Chair of our ASQ Sec on 0701 for 2016. I have been serving our sec on for a li le over 4 years, star ng as the Historian/Newsle er Editor, and the last 2 years as the Vice‐Chair. Inspired by a great group of professionals that are pas‐sionate about Quality and helping others with their professional careers, I decided to not complain and volunteer some of my me to join them in making a difference.
Our Leadership Commi ee and I discussed and approved a Business Plan for 2016 with objec‐ves that include membership growth, membership reten on, membership value, provide
valuable cer fica on opportuni es, and provide resources to our local business communi es to name a few. We are aiming at giving YOU, our members, the best value for being part of our ASQ Sec on. I am coun ng on our Leadership Commi ee to engage with me the ac ons to be bold, take our chances and drive our sec on to a be er place. However, we are only half of the success story, we s ll need YOU to be there to take advantage of it all.
I invite you to take advantage of the programs and resources that we will make available to you to further your careers. Make it a point to join us at our dinner mee ngs, seminars, oth‐er ac vi es and programs throughout the year. Don’t under‐es mate the importance of knowledge and networking opportuni es that our sec on brings to you. There is always a new thought, a new angle, or a piece of the puzzle that you could be missing to take your career to the next level.
Lastly, I want to thank Anet Ant for her contribu ons as the Chair for our sec on over the last couple of years. As one of youngest Leaders, she brought to our sec on a very important infusion of youth that our sec on needed to con nue being a benchmark ASQ group for gen‐era ons to come. She has been a great ambassador for our sec on at the World Conference for Quality and Improvement, Regional events and other ac vi es within our sec on. I wish Anet the best in her future endeavors and I look forward to her future contribu ons and achievements.
May you, your families and friends be blessed with a great 2016!
Dieter Eckstein, BSBM, ASQ CMQ/OE, CQA Sec on Chair, ASQ Orange Empire 0701
Dieter Eckstein, BSBM, CMQ/OE, CQA
- ASQ Orange Empire Section 0701 Chair
eScope January 2016
SOCIAL MEDIA CHAIR Jeffrey Snoddy [email protected]
MEMBERSHIP CHAIR Vatsal Patel ASQ0701membership‐[email protected]
AUDITING CHAIR Thomas Neal Email: TBD
NOMINATING CHAIR Dave Nagy [email protected]
VOC CHAIR Stan Themea [email protected]
SECTION 7 REGIONAL DIRECTOR Ed Ma hews ed.ma [email protected]
CHAIR Dieter Eckstein ASQ0701Vice‐[email protected]
VICE CHAIR Vinay Goyal [email protected]
TREASURER Cory Goral [email protected]
SECRETARY Laurie Pa on laurie.pa [email protected]
HISTORIAN Hyung Kim [email protected]
EDUCATION CHAIR Mark Lindsey [email protected]
CERTIFICATIONS/ RENEWALS Open Cory Goral (ac ng) [email protected]
CHIEF PROCTOR Hassan Farah [email protected]
PROGRAMS CHAIR Ned Schneider [email protected]
ARRANGEMENTS Vatsal Patel [email protected]
eSCOPE NEWSLETTER EDITOR Mike Chernobieff [email protected]
CAREER MANAGEMENT CHAIR Bob Mehta [email protected]
2016 Leadership Team
Page 2
eScope Ad Rates
Ad Size Approx. Inch Size
1 Issue 6 Issues 12 Issues
Full page 8.5” x 11” $200 $1,100 $2,000
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mailed to ASQ, PO Box 14183, Irvine, CA 92614, with ad copy, in‐structions for placement, and frequency.
Contact eSCOPE Editor: Mike Chernobieff @ Email: [email protected]
eScope January 2016
Congratula ons! Re‐Cer fica ons
The following members have met the requirements to be recer fied:
Are your certifications due for renewal?
You can submit up to six months before and after the due date. The recertification units must fall within the
recertification period. There is now an online RU Recertifica‐on Journal available! The RU journal allows logging in your
points as you earn them over the three year period.
h ps://asq.org/cert/myru
You can s ll send your recertification package to:
Alcon Laboratories A n: Cory Goral, M/C 122, CEE Lab
15800 Alton Parkway, Irvine, CA 92618
For more informa on or ques ons, please email [email protected] or
Click here for more informa on Or View our training videos
Vishal Kadakia Richard Basler Patricia George Carissa Pang Darrell Allen Tan Ha Tanvi Singh Nathaniel Doersam
Gary Leaf Stephen Powers Nasir Sufi Sukit Lertsun vit
Howard Shivers Melanie Nguyen
Karen Grams
Welcome! New ASQ Members
Welcome and congratula ons on making the important deci‐sion to become a member of ASQ.
All new members are eligible for free admission to a dinner mee ng within 3 months of becoming a member. Please con‐
tact Vatsal Patel for a free dinner voucher at: ASQ0701membership‐[email protected]
Mohammad Khalid
Stephen Knorr
Nadira Ahmad
Peg McCartney
Gus Martinez
Jonathan Chia
Kristoffer Kohl
Jessica Davis
Nikole Tong
Effie Paek
Geraldine Pena
Arthur Maczuga
Carlos Martinez
Jessica Brozek
Mark JJ Gilligan
Sergio Flores
Chad Bitterlich
Kohei Okimura
Tiffany Ngo
Camryn Reid
Kathleen Riola
Curtis Cash
Leslie A Osmera
Kirk Kauffman
Scott Buenger
Frank J. Vodhanel
James I Mellem
William Lynch
Sidney S. Colaco
Maria Salazar
Norma Gallardo
Swathi Nakkana
James W. Lester
Thinh C. Le
Timothy Quinn
Paul F. Brich
Hyunjoung Yang
Jacqueline Villanueva
Mohammad R. Elmasri
Brian Stoddart
Nathaniel B. Hayes
Victor Mendocilla
Emanuele Cantone
Jocelyn Chavez
Marcia Ocampo
Kevin Chang
Lake Trechsel
James McNamara
Edwin Johnson Yi Tien Tuan Vu anh Dang Ho Joel DiFonzo
Page 3
Page 4 eScope January 2016
Volunteering Opportuni es We are always looking for volunteers, but have an immediate need for the following posi ons.
For more informa on about any volunteering, please contact Vinay Goyal or email at [email protected]
We are always looking for Clinic and Dinner speakers!!
Certifications/Renewals Breakfast Meeting Chair
And more (e‐mail for details)
We are always looking for assistance with Dinner meetings, Clinics, and other events!
Inquire within!
Immediate Openings
eScope January 2016
Page 5
Page 6 eScope January 2016
Education Opportunities (Upcoming Refresher Courses)
Certified Manager of Quality & Organizational Excellence Course
& Exam Prep Will be held simultaneously as a Live Instructor Led Webi-nar in addition to a traditional classroom setting at Alcon
Labs.
SESSIONS/DATES 9 sessions; Mondays from January 11, 2016 to February
29, 2016 with 1 session TBA.
Will cover: Leadership, Strategy Development & Deploy-ment, Quality Management Tools, Customer Focused Or-ganizations, Supplier Performance, Management, & Train-
ing/Development. Plus, strategies/tips for preparing & taking the exam.
When Monday, January 11, 2016 6:00 PM - Monday, February
29, 2016 9:00 PM Pacific Time
Location Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618, USA
CLICK HERE TO REGISTER
Certified Biomedical Auditor Re-fresher/Prep Course
SESSIONS/DATES 10 sessions total:
Wednesdays from January 6, 2016 to March 2, 2016 1 session TBD (if needed)
Will cover: Audit Planning, Performing, Reporting, Follow-up, and Closure. Auditing / Compliance Programs, QSR /
US Law Related to Medical Devices. Quality System Regu-lation (Part 820). Other CFR Regulations, Quality Tools / Software, Laboratory Testing. Sterilization / Controlled
Environment / Packaging / Biocompatibility. Medical De-vice Directive. Standards and Guidance Documents. Plus,
strategies and tips for preparing & taking the exam..
When Wednesday, January 6, 2016 6:00 PM - Wednesday,
March 2, 2016 9:00 PM Pacific Time
Location Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618, USA
CLICK HERE TO REGISTER
Certified Quality Inspector / Quality Technician Refresher
Course
SESSIONS/DATES 9 sessions total. Mondays Jan 11, 2016 - Feb 29, 2016. 1
session TBA Will cover: Inspection & Test techniques and Methods,
Metrology, Calibration, GD&T, Basic Statistics, Statistical Process Control, Capability Analysis, Acceptance Sampling, etc. Also covers strategies/tips for preparing & taking the
exam
When Monday, January 11, 2016 6:00 PM - Monday, February
29, 2016 8:00 PM Pacific Time
Location Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618, USA
CLICK HERE TO REGISTER
Page 7 eScope January 2016
Leveraging Quality Tools Throughout the Organiza on
Applying design of experiments to mar-keting
by Akhilesh Gulati
Design of experiments (DOE) is a term familiar to most quality pro‐fessionals. Some use it on a regular basis and others try their best to avoid it. Most of those who em‐ploy this problem‐solving tool have done so mainly on behalf of quality improvement projects. Limi ng
DOE to just these areas or types of ini a ves results in huge lost opportuni es for these organiza ons, not even considering more personal missed opportuni es such as the failure to expand the professionals’ own skill sets.
Consider that organiza ons spend a fair amount of labor and financial resources on adver sing, specifically as it relates to its ming, media usage, channel selec on, and so forth. The assump ons that go into the ra onale for many of these decisions can be costly and significantly inhibit their effec veness. Why not apply this experiment‐based methodology to understand these rela onships? It would illuminate not only their complexity and counter‐intui veness, but also help determine the effect that ad‐ver sing, ming, product pricing, and more might have on sales.
Analyzing the value of an increased budget
Joe is the CEO of a large company. The vice president of marke ng approached Joe with a request to increase the marke ng budget to include addi onal adver sing in twelve marke ng areas. As usual, the VP defended his proposal on the basis of a projected increase in sales that he believed it would produce. This is something that came up annually during the budge ng process. However, this year Joe wanted to find out whether the organiza on received the value proposed by the increased budget—essen ally determining if there was an adequate return on investment for the addi onal expense. This analysis could benefit from a DOE perspec ve and would be a great opportunity for one of Joe’ Six Sigma Black Belts to apply this tool in a “non‐quality” ini a ve.
Wan ng to keep it simple, 50 percent of the requested increase in the adver sing budget was approved with the following caveat: Joe, the vice president of marke ng, and
a Black Belt would collaborate in selec ng six of the twelve areas to receive addi onal adver sing and the remaining six areas, with no addi onal adver sing, would be used as the control group. Marke ng had already created a forecast of monthly sales in each of the mar‐ke ng areas, and the intent was to measure the increase in the pre‐dicted forecast. Using sta s cal characteris cs of the forecasts, they es mated that they had a 95‐percent chance of increasing sales by 4 percent with addi onal adver sing in those six markets.
A er addi onal adver sing in the six areas was deployed and six months of data collected, analysis failed to reveal any significant difference between the test and control areas. Although there was a minor increase in sales over the forecast, the increased amount of adver sing did not jus fy the increased amount in sales. Under the past assump ons, without the sta s cal analysis, the observed in‐crease in sales would have been a ributed to the addi onal adver s‐ing.
Going beyond the ini al findings
This finding, however, encouraged Joe and his execu ve team to take a second step and try to determine the proper amount to spend on adver sing. They wanted to proceed with cau on, however, because they believed that much of their success was due to the quality of their product and the effec veness of how they communicated this through their adver sing. They decided to conduct an experiment in fi een market areas—areas where they had been trying to make ad‐di onal inroads. Their primary goal was to measure the effect of ad‐ver sing on sales—not on tradi onal measures such as recall rate or a tude toward their product. This would allow them to also under‐stand the causal (not merely the correla on) connec on of adver s‐ing on purchases (sales). Correla on could be misleading and become self‐serving; historical increases in adver sing were based on fore‐casts of increased sales and not the other way around.
They agreed on three treatment levels (a 25% decrease, no change, and a 50% increase in adver sing budget). Because adver sing alone does not determine sales, other important factors considered were point of sales and sales effort. Price was held constant. This led to a designed experiment, with three factors and three levels, conducted over a period of one year. The results did not agree with the ingrained expecta ons of the organiza on. In addi on, these results did not reveal any interac ons between the three factors. However, they did make the organiza on recep ve to the use of DOE outside of “quality.”
Con nued next page……………….
Page 8 eScope January 2016
Leveraging Quality Tools Throughout the Organization
Applying design of experiments to mar-keting
Continued……..
Previously, as part of on ongoing marke ng effort, the organiza on mailed out discount coupons of various amounts to be redeemed at specific retail stores; dis‐counts ranged from 2–40 percent. The goal was to achieve at least a 10‐percent response rate from the mail‐ings. As the marke ng department became more com‐fortable with the use of quality tools, they began to pro‐ac vely call upon the Black Belt to help. In this case they wanted to determine the percent discount that should be offered to achieve >10‐percent return response rate.
By using historical data and process modeling tools, the Black Belt was able to understand the rela onship be‐tween discount percentages and customer response. Re‐gression analysis indicated a fairly strong non‐linear rela‐onship.
Although a strong correla on was good, the original ques‐on s ll remained unanswered: What discount rate will
generate a minimum 10‐percent coupon redemp on by the customers? Ongoing process modeling ac vity and analysis was performed to come up with the following results: With 95‐percent confidence level, a discount cou‐pon of 18 percent should create at least a 10‐percent re‐sponse from the mailing and could generate as much as a 20‐percent redemp on. This made the discount coupon process more predictable for budget planning purposes, where ROI could be predicted and measured.
Although these were rather simple applica ons of quality tools to marke ng, it allowed the organiza on to use the DOE methodology and other quality tools in non‐tradi onal ways: op mizing its mar‐ke ng mix, se ng discount coupon levels, forecas ng customer pref‐erences, determining the effect of price on sales, designing marke ng brochures to influence conversion rates, etc.
DOE and process modeling methodologies have been successfully u lized in quality, engineering, and manufacturing over the last half century to op mize products and process designs. With li le effort, organiza ons can now benefit from these proven techniques to eco‐nomically op mize their marke ng returns (design and layout of liter‐ature, texts, web site, adver sing mix, etc.) by following a structured and data‐driven approach.
Bo om line: Leverage the skills of Six Sigma Black Belts (internal and/or external) for more than solving “quality” problems.
Page 9 eScope January 2016
Jack B. ReVelle, Ph.D.ReVelle Solutions, LLC
A Consulting StatisticianProviding Training, Advice & Assistance
Integrated Product andProcessDevelopment
Quality Function Deployment
GOAL/QPCASIHybrid
Design of Experiments
TaguchiShaininClassical
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Baldrige PE Awards ISO 9001 Lean Six Sigma
State Continuous Strategy PlanningQuality Process and Deployment
Awards Improvement Excellence System
Locally - BasedNationally -
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P.O. Box 10315Santa Ana, CA 92711-0315Phone: (714) 289-1664Cell: (714) 393-7672
E-mail: [email protected]
Fellow : ASQ, IIE, IAEJudge : USA Today Quality Cup
AZ Governor’s Award for QualityAwardsCouncil : CA Governor’s Award for QualityExaminer : Baldrige National Quality Award
aka The Wizard of Odds
Page 10 eScope January 2016
ASQ Orange Empire Monthly Dinner Meeting This is a special meeting program with two clinics running con-currently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presen-tation WITHOUT buying the dinner. In fact, we welcome you. We will have accommodations for you. This way you still earn
the RU and take advantage of the presentations.
PRESENTATIONS
Clinic 1: Implementing Effective CAPA System
Presented by: ASQ Fellow: Bob Mehta
Clinic 2: Process Validation: Proactive & Robust Validation Programs
Presented by: Peter Lindwall
Dinner Presentation: A Strategic Look at Design of Experiments
Presented by: Ned Schneider
WHEN Monday, Jan 11th, 2016, 5:15 PM - 9:00 PM
WHERE DoubleTree Hotel Santa Ana/Orange County Airport
201 East MacArthur Boulevard, Santa Ana, California 92707
FEES Clinic 1 or Clinic 2 ONLY (no dinner speaker or meal)
(0701 Member) Complimentary (Non-0701 Member) $10.00
Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal)
(0701 Member) Complimentary (Non-0701 Member) $10.00
Full Package - Clinic 1 or Clinic 2, Dinner, and Dinner Speaker
(0701 Member) $30.00 for a limited time ($40.00 original price) (Non-0701 Mem-
ber) $45.00 for a limited time ($55.00 original price)
RSVP by Friday, Jan 8, 2016 at 11:15 AM for discounted pricing and
Fish and Beef dinner selections.
Online registration closes at 12:00 pm on Monday, Jan 11, 2016.
CLICK HERE TO REGISTER
DINNER PRESENTATION
A Strategic Look at Design of Experiments
Presented by: Ned Schneider
Design of Experiments (DOE) is used to dramatically improve product and process innovation, effectiveness, and efficiency. DOE is the scientific approach used by researchers to build empirical mathematical models of product and process performance. These models are formulas that are used to optimize product and process performance while significantly reducing costs. DOE is considered the most powerful Six Sigma optimization tool and the Global Harmonization Task Force (GHTF) strongly encourages its use during medical device development.
By attending this clinic presentation, you will…
Understand why running a Design of Experiment (DOE) is superior to running a One-Factor-At-a-Time (OFAT) experi-ment.
Understand why changing the level of multiple factors simul-taneously in a DOE is acceptable.
Learn some drawbacks associated with low resolution experi-mental designs and a solution.
Understand that there is gold in those discovered 2-factor interaction effects.
Learn where the opportunities for process robustness come from.
Our speaker: Ned Schneider
Ned Schneider is a consultant and trainer with Advanced Response Engineering and has 20+ years medical device industry expe-rience as a Project Engineer and Director of Engineering working for several leading technology companies. Ned has received many Corporate Awards from 3M, Allergan and Advanced (Abbott) Medical Optics for outstanding performance that resulted in significantly improved product and process performance while reducing costs by millions of dollars annually. He says much of his
project success resulted from using Design of Experiments to gain new knowledge about product and process performance necessary for breakthrough business results.
Page 11 eScope January 2016
CLINIC # 1
Implementing Effective CAPA System Presented by: ASQ Fellow Bob Mehta
CAPA con nues to be the #1 reason for Form 483s and warning le ers for the past decade. Most companies have CAPA System but ques on is if the system is effec ve.
The presenta on will outline:
Elements of an effec ve CAPA system
FDA & ISO requirements
CAPA Data analysis
Defini ons
Root Cause Analysis
Ge ng to probable cause
CAPA meliness
Effec veness checks
Learning from experience
About our speaker: Bob Mehta
Bob Mehta is the Principal Consult‐ant & Recruiter at GMP ISO Expert Services (www.gmpisoexpert.com) and provides consul ng service in Pharma, Biotech, Medical Device, API, Food/Dietary Supplement, and Aerospace industries. Bob has over 25 years of experience, including as a Principal Consultant, in the Quality Systems, Training and Regulatory
Compliance areas. Bob is a Fellow of American Society for Quality (ASQ) elected in November 2014. He has wri en educa onal ar ‐cles in the areas of Quality and Compliance for Medical Device & Manufacturing (MD&M), Pharmaceu cal Technology, Quality Pro‐gress and Nutraceu cal World publica ons. He is an adjunct pro‐fessor at Cal State Dominguez Hills and Cal Poly Pomona teaches courses on Risk Management, Total Quality Management, Six Sig‐ma Black Belt, and FDA's Quality System regula ons. Bob authored the book “Implemen ng and Audi ng ISO/IEC 17025: A Prac cal Guide” which will be published by ASQ Press on April 15, 2013 and it is one of the best‐selling books based on informa on provided by the ASQ Headquarters in October 2014 and the book received 4.7 out of 5 stars ra ng on Amazon.com (based on 9 customer re‐views) and a link is included below:
h p://www.amazon.com/Implemen ng‐ISO‐IEC‐17025‐Prac cal‐ebook/dp/B00C2XQK70
Bob has co‐authored a book tled “Process Valida on” and it is on schedule to be published in Q1 2016.
CLINIC # 2
Process Validation: Proactive & Robust Validation Programs
Presented by: Peter Lindwall
Topic: CURRENT BEST PRACTICES & REQUIRED BASICS
Process Valida on is not only a requirement of many regulated in‐dustries but when done right is a tool that can posi vely impact business performance. This session will cover the different types of valida on, elements of a successful process valida on, associated regulatory requirements and their origins, and how to proceduralize process valida on such that the quality system drives robust valida‐ons. You will learn to strategize and plan prospec vely rather than
retroac vely for maximum benefit to your business.
Takeaways: Quality System & Valida on Strategy
Valida on Checklist
Working Examples
Applicable Regula ons & Guidance's
Please bring your ques ons, experiences, and other commentary to make this a more valuable experience.
About our speaker: Peter Lindwall
Peter Lindwall holds a BS in Chemi‐cal Engineering, an MS in Quality Assurance, and an MBA in addi on to CQE, CMQOE, CQA, CBA, CSSBB, and RAC EU and US cer fica ons. Peter has an impressive breadth and depth of knowledge having worked project engineering, quality engineering, manufacturing engi‐neering, and regulatory affairs in both startup companies as well as large established corpora ons. Peter is currently a Manager of Regulatory Affairs at Edwards
Lifesciences where Edwards is able to u lize Peter’s vast engineering exper se and regulatory knowledge for product development and sustainment.
Page 12 eScope January 2016
Upcoming Conferences for 2016
For more informa on about any conferences, please check the ASQ.org website!
