Why People are Talking About the Medical Device Quality Congress…

“As a repeat attendee, I highly recommend this conference. The workshops, interactive sessions and insights from reputable speakers are very useful and applicable information to take back and share with my company and colleagues.”
Heather Jalisi, Quality Assurance Manager, DexCom Inc.

“I would recommend the seminar in view of strengths of topics discussed and speakers who are well respected in industry.”
Remy Estera, Team Leader, Quality Assurance in Manufacturing, Resmed Ltd. Australia

“It was extremely refreshing to attend a conference with the focus on Medical Devices. Too often with conferences the focus is on drugs. This conference was very well done!”
Joseph Sondej, Associate Manager Quality Control, Celgene Cellular Therapeutics

“One of the most beneficial Congress’ I have ever attended.”
Alejandro Lamas, Quality Assurance Manager, Medtronic Mexico

“Compilation of insightful presentations, covering issues faced by every device manufacturer, presented by industry leaders.”
Chris Lake, Manager Quality Assurance and Regulatory Affairs, Epimed International

Pre-Conference Workshops
Tuesday, May 2, 2006

Workshop A - AM Half-Day - 8:30am-11:30am
Complying with FDA and ISO Software Verification and Validation Requirements

INSTRUCTOR:
	Dennis Rubenacker Senior Partner Noblitt & Rueland

Implementation of Software Verification and Validation (V&V) is extremely important for ensuring the safety and reliability of medical device & manufacturing software. U.S. FDA in 21 CFR Part 820 with related guidance and ISO 13485:2003 require Software V&V. Medical device manufacturers need to understand and address these quality system requirements.

This workshop will focus on methods and strategies for applying appropriate and efficient software V & V strategies for a wide variety of software used by medical device manufacturers for the device, device production & implementation of the quality system.

What you will learn:

FDA & ISO Software V&V requirements
FDA Software Guidance Documents-impact on V&V strategies
Manufacturing software requirements for V & V
Software and Risk Management
Requirements for 3rd Party and OTS software
V & V documentation required for device submissions
How to determine appropriate software V & V strategies

Benefits of Attending:

Complying with FDA & ISO V & V requirements
Reduce 510(k), IDE, PMA, CE Mark submission delays
Implementing efficient V & V strategies
Prepare for FDA inspections and ISO audits

Workshop B - PM Half-Day - 1:00pm-4:00pm
CAPA Warning Letter Prevention

INSTRUCTOR:
	John Malloy President John Malloy & Associates

Examples of warning letters will be used throughout this workshop to help participants understand how to avoid receiving a warning letter and how to respond to one when received.

Understanding the CAPA requirements
1. Overview of the requirements
2. Different approaches to compliance

How to design your CAPA system
a. process design
b. communications methods

Inputs to CAPA
a. nonconforming product
b. complaints
c. process monitoring
d. environmental monitoring
e. audits other quality data sources

Getting down to the specifics
a. analysis
b. investigation
c. actions
d. verification or validation
e. notifications to personnel
f. management communications
g. documentation

Here’s what participants at the inaugural Medical Device Quality Congress said about John Malloy…