You asked for it – you got it!

The Certified Biomedical Auditor Preparation Classes is being offered for the first time by MNASQ due to overwhelming demand!

CMQ/OE and CBA Preparation Classes for Oct 5th, 2013 Exam

Certified Manager of Quality/Organizational Effectiveness,   6-9pm, 8 Sessions starting on Wed, 07 Aug 2013, ending on Wed, 25 Sept 2013 ($540 for members; $640 for non-members) Registration closes July 24th.

Certified Biomedical Auditor,    6-9pm,     8 Sessions starting on Thurs, 08 Aug 2013, ending on Thurs., 26 Sept 2013 ($540 for members; $640 for non-members) Registration closes July 25th.

Register for the exam at ASQ.org and purchase your study materials through Quality Council of Indiana so you can get a head start.  Exam registration date is August 16, 2013.

For more information contact: Meena Chettiar at 612-747-9635 or meenachettiar.mc@gmail.com for additional info.

CBA is a good progression for CQA certified professionals working for medical device manufacturers, contract manufacturing and testing facilities. Quality professionals working for the medical device industry at all levels ranging from supplier auditors, compliance specialists to facility managers in the medical device industry will benefit from taking the CBA class for continuing education credits and to prepare for the upcoming CBA certification exams in October 2013 or March 2014.

Tuesday, August 13th on Lake Minnetonka for our annual Summer Networking Cruise.

When:  Tuesday, 8/13/2013

5:45 PM to 9:00 PM (Light snacks will be provided)

Where:

Lady of the Lake Cruises
Downtown Excelsior, MN
Lake Minnetonka
952.929.1209

Registration Coming Soon!

Don’t forget to bring plenty of business cards!

Meeting Location Map and Directions

From Minneapolis, take I-394 West to I-494 South.  Exit 6B to MN-7 West.  Follow MN-7 west to County Road 19 (Oak St.), turn right.  Drive one block to Water Street, turn right.  Continue until you reach the bay. (Approximately four blocks.)  Welcome to the Port of Excelsior!

Parking Directions

There is metered parking available in front of the Port of Excelsior on Lake street. If the metered parking is full you will find ample parking lots within walking distance.

Unemployed?  Check out our Refresher Course Grant Program.

But you can improve your odds and maximize your investment by taking MNASQ certification exam prep classes. More than 90% of our students pass the exam the first time!

Meet our instructors

But we don’t stop there. Our guarantee: If you don’t pass the exam, you can re-take the class free of charge.

Full Course Schedule

The following classes will be offered in preparation for the October 2013 Certification Exam.

Certified Biomedical Auditor

Certified Manager of Quality / Organizational Effectiveness

Certified Reliability Engineer

Six Sigma Black Belt

Check out this webinar on certification exam tips, trips & traps

The speaker will be Korina Akhondzadeh from KARA & Associates, Inc.  Attendees will learn the differences between US regulatory requirements under 21 CFR Section 820 vs. the requirements under ISO 13485:2003, this standard being a voluntary standard.  We will also provide tips on writing audit plans, collecting evidence comparing audit finding to criteria and a basic comprehension of auditing techniques under ISO 19011:2011.   Areas the session will cover are:

• Understanding compliance and difference between 21 CFR Section 820 and ISO 13485:2003 (a brief review of EN ISO 13485:2012 -harmonized EU version)
• Medical Device Reporting 21 CFR 803
• Device Tracking 21 CFR 821
• Risk Management
• EU MDD
• Tips on audit preparation
• Getting good audit evidence
• Audit report writing
• Auditing techniques
• Audit Follow-Up

This session provides clear explanation and basic concepts between the US regulation/ISO requirements and practical auditing techniques to help you successfully perform and complete good internal and external audits at your business.

When:

Friday May 17, 2013 (8:00 am – 3:30 pm) – (Check-In begins at 7:30 AM)

Where: 

St. Cloud State University Graduate Center
6401 Sycamore Court North
Maple Grove, MN‎ 55369
(320) 308-6000

Cost:

Minnesota ASQ Member – $225
ASQ Enterprise Member- $225
Non-Member – $250 

Continental Breakfast, Lunch, and Break Snacks are included.

Registration closes Monday, May 13th at noon.

Certificates of Completion: Issued on workshop completion for 0.7 ASQ RUs.

Who Should Attend: Engineers, Management, Auditors and other Employees responsible for Auditing, Quality, Reliability,

Regulatory, Production, and Development at Medical Device Manufacturers.  Suppliers,

Contract Manufacturers, and persons interested in the Biomedical Industry will also find this workshop valuable.

Instructors Bio:

From the late 1980s until 1996, Korina Akhondzadeh worked in the Medical Device Industry in Regulatory Affairs and Quality Assurance.  In those positions, she was responsible for a variety of RA/QA functions including ensuring compliance with FDA QSRs (21 CFR Section 820), EU directives and other international regulations. Her work included auditing, Medical Device international submissions and FDA 510(k) preparations, product registrations, training, ISO implementation and CE Marking requirements. Korina holds a Bachelor’s degree in Public Relations and actively speaks on regulatory topics for various national as well as international organizations such as: RAPS, AMDM, SDRAM, USC, SDSU, and others.

From 1996 until 2003 Korina worked  for  various  Notified Bodies including BSI, TUV Rheinland, ITS and TUV SUD working with the Medical community.  In 2003, Korina joined KARA & Associates as a Partner and a Senior Regulatory Consultant. In addition to her consultancy role, Korina actively serves as a qualified BSI, SGS, Nemko, and TUV SUD instructor for various courses offered.

This presentation will be on the practical application of ISO 14971, the medical device risk management standard. Discussion will include the meaning of the requirements, as well as tools and techniques to be used meet the requirements of the standard as well as incorporating the requirements into the Quality Management System.

The FDA QSR requires that “Design validation shall include…risk analysis“. In addition, a FDA Reviewer’s Guidance requires that a “Hazard Analysis” be completed and included for the approval of submissions.  ISO 13485:2003 specifically recommends that ISO 14971 be used when managing risk; which is required when obtaining a CE Mark, and the new draft of ISO 13485 emphasizes it even more.  Risk management and ISO 14971 has also become very important and a hot topic when complying with IEC 60601-1 3rd Edition.

When:         May 8, 2013, 8 am to 4:30 pm.  Registration and breakfast begin at 7:30 am.

Presenter:         Edwin L. Bills, Principal Consultant at Bilanx Consulting LLC

Where:
Crowne Plaza Minneapolis West  (Formerly Radisson Hotel and Conference Center)
3131 Campus Drive, Plymouth, MN 55441
(763) 559-6600

Cost: 
$250 – MNASQ members/partners
$275 – non-members
Includes materials, continental breakfast, lunch and breaks.

NOTE:  Handouts will be in electronic format & emailed to attendees prior to or after the event SO SIGN UP EARLY TO GET YOUR HANDOUTS PRIOR TO THE EVENT!

TO REGISTER:  http://a3.acteva.com/orderbooking/bookEvent/A334393

              Registration closes May 3, 2013.

RU’s:    0.8

Your Speaker:  Edwin L. Bills

Edwin Bills, Principal Consultant, Bilanx Consulting

Mr Bills was one of the originators of the ISO14971 Standard.  During his 22 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions.  Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Excellence.  He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, as well as a BS and a Masters degree from the University of Cincinnati.

Mr. Bills is a current member of the US national committee on medical device risk management and also the US national committee on medical device quality management systems.  He serves on the adjunct faculty for the Virginia Tech Health Products Risk Management Program.

Mr. Bills has presented training courses in risk management and quality systems both domestically and internationally, for industry personnel and for regulators.  Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC (www.bilanxconsulting.com) in the area of medical device quality, regulatory, product liability, and risk management.

This year’s conference theme is “The ROI of Excellence”.  The hallmark event will be held May 14-15 at the Earle Brown Center, Brooklyn Center and will feature 20+ high performing organizations from Minnesota and across the US as they share their best practices on what drives performance excellence.

Keynote speakers include Irving, TX’s City Manager, and CEOs of Southcentral Foundation (healthcare) and K&N Management (restaurants).

More than 400 leaders/professionals are expected to attend, so the event should offer excellent learning, sharing, and networking.

For more details and to register:
http://performanceexcellencenetwork.org/events/penworks-2013-the-roi-of-excellence/

Select the partner rate and type ’1203′ in the comment box.  

Back by popular demand! Come learn this key skill from two extremely qualified and well-known local practitioners.  Process validation is a vital part of the total business environment and an activity that is the focus of FDA inspections of medical device manufacturers and their suppliers. This seminar will provide you with valuable information and examples that you can use in your own companies.  The speakers will be Ashweni Sahni, of Ash & Associates, and John Kim, Consultant, recently retired from Medtronic.

You will learn about developing a capable, consistent and controlled process for production that can be a challenging yet extremely rewarding experience.  The rewards/benefits of the resulting improved quality include:

•    consistent compliance,
•    minimized business risk,
•    elimination of scrap,
•    reduced costs,
•    improved overall customer satisfaction.

This session provides validation principles, GHTF guidance, FDA-related information, practical examples, and case studies to help you successfully perform and complete process validation at your business.

About the Speakers
Ashweni Sahni is President of Ash and Associates, a quality and compliance management consulting company. He is Fellow of ASQ, past-chair of the Minnesota Section of ASQ, and has presented numerous papers and seminars/workshops on diverse quality subjects including process validation.

John Kim is a consultant with over thirty five years experience in statistical consulting.  He joined Medtronic in 1975 as a statistician and worked in various groups including Applied Research, Marketing, Finance, Corporate Statistical Resources, and Corporate Quality and Regulatory Affairs. Prior to his retirement from Medtronic, he spent 7 years as the Director of Quality Technology. He is still actively involved in medical devices industry as a consultant. John is a certified Master Black Belt, a member of the American Society for Quality (ASQ). He chairs the ISO committee on Application of Statistical Methods in Process Management (TC69/SC4).

WHEN:    Tuesday April 23, 2013; 8:00 am to 5:00 pm (registration 7:30 am)

WHERE:    Embassy Suites, Brooklyn Center

COST:    MNASQ Members – $225, ASQ Enterprise Members – $225, Non-Members – $250
All materials, continental breakfast, lunch and breaks will be provided.

RU’s:    0.8 RU’s will be awarded those completing the workshop.

WHO SHOULD ATTEND:    Quality, Reliability, Production and Development employees of device manufacturers, suppliers & contract manufacturers, and persons interested in the biomedical industry.

TO REGISTER:    Go to http://a3.acteva.com/orderbooking/bookEvent/A333799

Register early.  Space is limited.  Registration closes April 18.

The results are satisfaction, product and improved performance. increased and service
company customer reliability, financial performance.

The results of Six Sigma can be outstanding if properly supported by management. The
project completed by one of the participants in our Six Sigma Practitioner program
saved $226,000 for the year and reduced their order cycle time from 18.5 days to 4.5
days. Furthermore, his project had a cost avoidance of $456,000.

When: Thursday, April 18, 2013, 8:00 am – 4:30 pm

Fee: $245.00

Where:  Cabela’s in Owatonna

Download Brochure for Practical Applications of Six Sigma

Training objective: To provide an understanding of the structure, methods, techniques,
and financial gains from Six Sigma.

The principles and methods taught in this seminar apply to manufacturing companies
and service organizations equally.

Who should attend this seminar?

Executives, managers, engineers, and anyone who
wants to discover the future of organizational management m the cost competitive
world economy.

On completion of this seminar you will:
• Learn the background of Six Sigma, the strategies, metrics, and the DMAIC
methodology
• Learn about the deployment of Six Sigma projects, and to integrate these into bottom
line profits.
• Learn the first phase of a Six Sigma project, Define and the metrics to use such as RTY,
CTQ, KPOV, KPIV, DPMO, and Cost of Quality.
• Preview basic measurement and problem solving tools; Pareto analysis, flowcharting,
cause and effect diagrams, etc.
• Learn how statistical methods are used in Six Sigma and yet, that not all projects
require sophisticated statistical tools.
• Preview analytical techniques for higher level projects such as; test planning & design,
hypothesis testing, ANOV A, and regression analysis
• Learn how you as an individual can use the tools and the Six Sigma model.