Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

[Adam Fleming]

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.

Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process.

A learning session

To gain a better understanding of these important aspects of CAPA; MentorHealth, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within Regulatory Affairs, will be the speaker at a webinar that. Please register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500837

This webinar will help participants understand the role of analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data in identifying existing and potential causes of nonconforming product, or other quality problems.

Use of the right statistical methodology

It will also equip them with the knowledge of the use of appropriate statistical methodology, where necessary, to detect recurring quality problems. It will underscore the point that a well written policy and procedure on setting up and maintaining the system is just the first part of the process and that it needs continuing monitoring and upgrading.

This session will teach participants ways of conducting a CAPA investigation and the use of the tools that make it incontestable. The speaker will provide an overview on identifying recommended practices to improve, streamline, refine, retool and develop, deploy and maintain a viable and sustainable CAPA system.

David will cover the following areas at this webinar session:

o  How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria

o  How to facilitate a product complaint investigation as part of your CAPA program

o  What is a closed-loop investigation…cradle to grave approach

o  How to conduct an investigation using a well-written CAPA policy and procedure

o  Understand and comprehend what FDA is looking for in meeting minimum expectations…no Band-Aid solutions

o  Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice

o  Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions

o  Develop and deploy escalation rules and criteria to facilitate decision-making process

o  Understand what it takes to conduct a “quality” investigation to ascertain the root cause

o  Review and discuss recent CAPA red flags and FDA enforcement actions.