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Workshops are held once per month (4th Wednesday) as a cost effective way to keep up to date on quality practices, and to network with some of the best quality professionals in industry.  Dinner & 0.3 re-certification units included.  Held in meeting rooms upstairs.    See feedback from past workshops,  "... the workshop was AWESOME!", or  "... the best investment I've made in years".   Jump Below to:

Typical Workshop (4/2002)

This Month's Workshop

Upcoming Workshops

Past Workshops RSVP Form

This Month's Workshop

 

TOPIC 

Taught By

Date

Cost

Contact

"FDA Compliant Design Verification and Validation"

Hank Posters

April 23, 2003  

$50 Members with Reservation, $60 "Non Member/Day of the Event"

Don Griego

Special guest talk on V&V P's & Q's by Kim Niles

   

Abstract:

 

Are you required to perform Design Verification and Validation activities?
Are your companies Design V & V practices compliant to the FDA?

Can you answer the following questions?
1. Who is responsible to perform Design V & V activities?
2. What quality tools are needed to perform Design V & V activities?
3. When are accelerated testing methods appropriate?
4. Where can I find the FDA’s Quality System Regulation requirements for V & V activities?
5. How do I structure test plans & test report documents?

This presentation is for anyone working in any industry that is interested in V & V but it will place a special emphasis in how the FDA's Quality System Regulation has put renewed focus on design verification and validation test practices.

 

This workshop will give participants an overview of design evaluation and validation test principles most applicable to the medical technology industry. Requirements for developing and executing sound test plans, including some of the statistical and quality tools needed, will be discussed. Basic principles of accelerated testing will be explained. Also the documentation aspects of design evaluation and validation testing will be reviewed with practical suggestions on structuring test plans & reports.
 

About Our Speaker:


Henry Posters is a Registered Professional Quality Engineer with extensive experience in the field of implantable medical devices. He is familiar with product requirements in the United States and Europe.

 

Mr. Posters holds a BS degree in Electrical Engineering and an MBA in Manufacturing Management. He is a senior member of the American Society for Quality. He is an ASQ certified Quality Engineer, Reliability Engineer, and Quality Manager.

 


Dinner will be served promptly at 5:30 and the program will begin at 6:00 PM

Location:   Ericsson Building

Time: 5:30 PM – 9:00 PM   

Address6455 Lusk Boulevard , San Diego, CA92121

 

If you are interested in attending this workshop, please fill out and submit the following on-line form and bring a check to the meeting, or you can mail this form with the check made out to ASQ, San Diego Section 0703 to   * spaces are mandatory

*Name: 

Job Title:

*Email:

*Payment Plan: 

 

$50 Members with Reservation

Check or cash at the meeting

I have mailed this form with the check 

$60 "Non Member/Day of the Event"

Check or cash at the meeting

I have mailed this form with the check 

Cancellation

It's not the day of the event, please cancel me with no penalties. 

It's the day of the event, please cancel me and contact me of fees.

Member #: 

used for the .3 re-certification units

 Phone (H):

Phone (W):

Company:

 Mailing Address:

  

Press submit to register for our workshop


Upcoming Workshops (Chronological Order):

TOPIC / Link

Taught By

Date

Cost

Contact

5S Methods In Depth

 

Diane Geldreich

May 28, 2003

$50/$60

Don Griego

Inthinking & Enterprise 

Thinking Concepts

William Bellows, Ph.D.

June 25, 2003

$50/$60

Don Griego

"Steven Covey & Time Management Principles" 

 

Karin Riggs

July 23, 2003

$50/$60

Don Griego

More soon

  August    

More soon

  September    
Open  

Nov. and beyond

$50/$60

Don Griego

Hoshin Planning  

Hoshin Handbook

Pete Babich

Post September or backup

Special pricing to cover his book

Don Griego

Short Run Techniques of SPC Charting

Bill Evans

Backup

$50 Members with Reservation, $60 "Non Member/Day of the Event"

Don Griego

 

If you or your company has special education needs or special interests in hosting or presenting a workshop, please contact Don Griego.


Past Workshops (Reverse Chronological Order):           

TOPIC / Link

Taught By

Date

Cost

Contact

FDA Compliant Design Verification and Validation

Hank Posters & Guest talk by Kim Niles

April 23, 2003

$50/$60

Don Griego

  "Converting a Quality Management System using the Process Approach"

Roland Kelly &Julie Drysdale

March 2003

$50 Members with Reservation, $60 "Non Member/Day of the Event"

Don Griego

Quality Function Deployment (QFD)

Keith Boyle

Feb. 26, 2003

$50 Members with Reservation, $60 "Non Member/Day of the Event"

Don Griego

Lean & Theory of Constraints

Jane Marshall

 Jan. 29, 2003

$50 Members with Reservation, 

$60 "Non Member/Day of the Event"

Don Griego

  We had no workshop in December 2002

  We had no workshop in November 2002

Internal Audit Techniques

Diane Geldreich

October 23, 2002

$40 Members with Reservation, 

$50 "Non Member/Day of the Event"

Don Griego

Statistics for Quality Engineering: DOE and other techniques

Dr. Leonard Perry

September 25, 2002 

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

ISO 13485, The Global Device GMP

James E. Stanley, MS

Regulatory/Clinical Consultants, Inc.

August 28, 2002 $40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

Lean Manufacturing 101:  The Basics & Getting Started

Roger Olson - Partner 

Systems Quality, Inc.

July  31, 2002

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

The Application and Interpretation of Geometric Dimensioning and Tolerancing (GD&T)

Michael A. Sandford is the President of Technical Documentation Consultants of Arizona, Inc.

Wed. June 26, 2002

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

  We had no workshop in May 2002

ISO 9000:2000 Transition

Diane Geldreich, et.al.

Wed. April 24, 2002

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

  We had no workshop in March 2002

Using Excel for Statistics

Dr. Jim McMahon

Wed. Feb. 27, 2002  

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

Six Sigma Calculations 

Rich Ostrin  

Wed. Jan. 30, 2002

$30

Don Griego

"Transition to ISO 9001:2000 Without Tears" Mr. Vinod Kumar, founder President of ISOguru, Inc. October 24th from 5:30 to 9:00 P.M. 

$30

 

Don Griego

Combined meeting & workshop. This 2 hour Workshop on "Regulatory Audits and QSIT".  See Sept. meeting topic   Barbara Moynier  - Senior Food and Drug Investigator and her colleagues September 26th from 5:30 P.M. to 9:00 P.M. midweek training opportunity

$30

 

Don Griego

Understanding Engineering Drawings

Don Griego

Aug. 2001

$30

Don Griego

GMP & ISO Compliance

 

Click Here For Information

Refresher courses held at National University.  See our Education page 

Click www.pqsinc.org or call, or email sharky.watkins@pqsinc.org 

 

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San Diego, CA 92192-8457

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  Monday December 21, 2009 

 

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