Corrective and Preventive Action Workshop for Regulated Professionals

Shorten and better manage CAPA investigations for life sciences

Published: Friday, December 17, 2010 - 14:53

(MasterControl: Salt Lake City) -- Some of the most stringent corrective and preventive action (CAPA) policies have caused hosts of compliance issues for life-science companies throughout 2010. Come learn from the MasterControl and Pathwise experts at a hands-on CAPA workshop—gain the knowledge and practical tools necessary to help shorten and better manage your CAPA investigations to improve product quality and ensure compliance.

MasterControl and Pathwise industry veterans have successfully trained hundreds of life-science companies to improve CAPA and quality processes. They have worked closely with the Food and Drug Administration (FDA) to train investigators on the latest CAPA investigation and resolution techniques. As consultants, they have worked on a variety of high-impact problems, including product recalls where they have discovered root causes that have saved companies more than $20 million.

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The course will also provide skills and tools to eliminate the following common CAPA problems:

• Countless open CAPAs with no resolution and too many people involved • Internal investigators who can’t solve problems and find causes
• Ineffective processes to utilize with personnel presenting data for root cause analysis
• CAPA processes that don’t pass global FDA and EMEA standards
• No uniform, solid method for investigating problems
• No process for verifying and validating corrective actions

Workshop overview

The workshop is taught using a blended approach of classroom and real-life application. This “how-to” approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting. You will learn about:

• Quality events—Examine the feeders to your CAPA system and learn to manage complaints, deviations, audit findings, and seven other quality events. Feeders will also be examined and key questions regarding CAPA forms will be discussed.
• Issue review—Identify and prioritize events based on risk. Set up risk gateways into electronic solutions
• Root cause analysis—Investigate systemic issues to identify underlying causes
• Implementation and effectiveness checking—Solution selection, verify and validate, implement, monitor, and confirm success

Skills you will learn

• Assess and prioritize each event based on risk and map form-to-form risk filters
• Gather relevant information through specific, focused questioning
• Pinpoint root causes using facts instead of guesswork or opinion
• Integrate intelligence into forms and set up guidance paths that are based on regulations
• Avoid costly experiments and trial fixes by logically testing possible causes
• Target potential problems before they happen and develop actions to prevent them
• Effectively involve others in the investigation process
• Check effectiveness of corrective and preventive actions
• Document the analysis in an easy-to-use, logical, and defensible format

Who should attend?

This course is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples of attendees include investigators, laboratory technicians, quality assurance personnel, managers, manufacturing supervisors, and engineers.

Presenters

Nathan Conover, senior partner of PathWise
Ken Peterson, director of quality solutions at MasterControl Inc.

About The Author

MasterControl Inc.

MasterControl software solutions incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment companywide. MasterControl solutions include quality management, document management, product life-cycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more.