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Highlights from last year's conference:

“Excellent forum to meet people from the industry and FDA in a relaxed setting.
Russ Davies, Vice President, Regulatory Affairs and Quality Systems, Smiths Medical, NA

“This conference was very enlightening, especially in trends regarding quality.
Bob Jaksih, Director of Technical Services, Perkins Electronics

...the FDA’s list of recalled devices that could pose serious health problems or death has grown over the last five years, with  18 so far this year...”. 

The Boston Globe, September 1, 2004


Pre-Conference Workshops:
Tuesday, April 5

Pre-Conference Workshop A - AM Half-Day Session
CAPA - Management and Executive Responsibility

John Malloy
John Malloy and Associates, Inc.

  • Understanding the CAPA requirements

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

  • How to design your CAPA system
    1. Process design
    2. Communications methods

  • Inputs to CAPA
    1. Nonconforming product
    2. Complaints
    3. Process monitoring
    4. Environmental monitoring
    5. Audits
    6. Other quality data sources

  • Getting down to the specifics
    1. Analysis
    2. Investigation
    3. Actions
    4. Verification or validation
    5. Notifications to personnel
    6. Management communications
    7. Documentation

Here’s what participants at the inaugural Med Device Quality Congress said about John Malloy and why we’ve expanded the length and depth of his presentation…

  • Great! Not enough time!

  • Excellent examples from when John was an FDA investigator

  • This presentation was fantastic. I wish he had a longer time to speak.

  • Excellent talk. I believe this could be a 1.2 day talk.

  • Best presenter of the seminar!

  • Excellent presentation. Speaker was extremely knowledgeable of the topic

  • Very informative and well presented

Pre-Conference Workshop B - PM Half-Day Session
Software Validation
INSTRUCTOR: Armin Torres, Principal, Qualified Data Systems [BIO]
  • Understanding Software Validation
  1. Defining the scope

  2. Understanding impact to the business

  3. Understanding the Systems-Engineering perspective

  • Executing a Master Plan
  1. Developing and Maintaining an Applications Portfolio

  2. Assessing the need for validation

  3. Defining a risk-based approach to prioritize validation efforts

  4. Identifying the impact of 21 CFR Part 11 on the validation efforts

  • Implementing a robust validation methodology
  1. Using a life cycle approach

  2. Defining the essential set of supporting processes and procedures

  3. Evaluating cost and resource requirements

  4. Developing a cost-effective approach to execution

  • Implementing Compliance Strategies for Remediation of Computer Systems

  1. Performing Gap Assessments

  2. Using the Six-Sigma Approach for Problem Solving

  3. Identifying the hidden costs in Remediation

  4. Implementing corrective and preventive measures

  5. Monitoring for effectiveness

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