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Process Validation and Integrating Risk Management

ASQ Biomedical Division

Wednesday, May 31, 2017 at 8:00 AM - Thursday, June 1, 2017 at 4:30 PM (CST)

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Process Validation has always been a challenge for medical device manufacturers.  Improper or ineffective process validations have resulted in a significant number of Warning Letters.  End-of-the-line production testing alone is not enough to ensure quality of your manufacturing processes.  Validation planning is now expected to include the integration of risk management.

You're not alone, help is on its way. The Biomedical Division has designed this two day conference to provide you with help from subject matter experts. 
Tentative Agenda
 

May 31, Wednesday, Day 1, 8:30AM – 5PM


Registration Starts

7:30 am  

Breakfast

 

7:30 am

Welcome and Introduction

Logistics, RU’s, Summary, 3 x 5 Cards, “sitting next to someone new,” email sharing list

Jim Shore and Edwin Garro, Program Co-Chairs

8:30 am

Why ASQ Biomedical Division?

Introduction, Officers, Kimberly McCoy, ASQ Biomedical Division Chair

8:45 am

Key elements and overview of Process Validation e.g. MVP, IQ, OQ, PQ

Karen Brozowski/Anna Jensen

9:00 am

Break

10:00 am

FDA perspective on Process Validation

Ricki Chase

10:15 am

Best practices for Process Validation

Mark Durivage

11:15 am

Lunch

12:15 pm

Software Validation – Risk Based Validation for Laboratory Information Management Systems (LIMS)

Arta Doci

1:00 pm

Break

2:00 pm

Process Validation from the Manufacturer’s perspective

David Rothkopf

2:15 pm

Process Validation interactions with MDSAP audit program

Captain Lewandowski-Walker (Invited)

3:15 pm

Wrap up

Speaker Panel/Q&A from today’s discussion
Logistics for the next day e.g. start time, logistics for luggage, getting to airport,etc.

Day 1 Survey

4:15 pm

 

 

5:00 pm

 

June 1, Thursday, Day 2, 8AM – 5PM

Breakfast

7:30 am

 

Welcome back

Logistics, 3 x 5 Cards, next conference

Jim Shore and Edwin Garro, Program Co-Chairs

8:15 am

 

 

Next Conference in Canada

Scott Blood, Audit Conference Chair

8:25 am

 

Introduction to PFMEA and connecting the DFMEA to the PFMEA

Bob Launsby

8:30 am

Best practices using statistics with validation

Cesar Libby

9:30 am

Break

10:30 am

MDSAP Best practices for Process Validation for sterilization

Captain Lewandowski-Walker (Invited)

10:45 am

Changes to the European Medical Device Regulation

Roger Echeverría

11:45 am

Lunch

12:45 pm

Risk Management integration into the business

Mark Durivage

1:00 pm

How suppliers affect your validation and best practices to reduce variations

Ricki Chase

2:00 pm

Break

3:00 pm

Advanced Process Risk Management tools e.g. Process Hazard Analysis, Hazard Analysis and HACCP

Barry Craner

3:15 pm

Wrap up

Speaker Panel/Q&A

Day 2 Survey

Issue RUs

4:15pm

 

 

4:45 pm



This outstanding two day conference is only $499 if you register before April 15. If there's still space available, it will cost $599 begining April 16, still a great value.

Come to San Jose, Costa Rica for Wednesday, May 31 and Thursday, June 1. Get expert knowledge plus advice from your peers. 
 
Click below for Special Lodging Rates - Book by 4/15/2017!!!!
 
 
contact the Costa Rica Marriott Hotel San Jose directly at +506-2298 0000
 

 
FDA Keynote Speaker CAPT Kimberly Lewandowski-Walker (invited)
You've seen her on ASQ TV- now hear her in person and get the message firsthand.
 

 



 1.6 RUs for this conference.  
Have questions about Process Validation and Integrating Risk Management? Contact ASQ Biomedical Division

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When & Where


Costa Rica Marriott Hotel San Jose
La Ribera de Belen
Heredia
Costa Rica

Wednesday, May 31, 2017 at 8:00 AM - Thursday, June 1, 2017 at 4:30 PM (CST)


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