Corrective and Preventive Action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement. Learn how to not only meet current and future regulations, but also how these regulations can be implemented correctly in order to be effective and profitable for your company. This is invaluable for organizations regulated by the FDA, or those concerned about regulation, including medical device; pharmaceutical; vitamin, nutraceutical, and supplement; tobacco; and ISO 9001- and ISO 13485-registered companies.

Objectives

• Understand what is included in an effective CAPA program and where the data comes from.
• Discover how to use internal and competitive external data to make your organization more profitable.
• Learn what the FDA and other regulatory officials are finding and using to put the pressure on others in the industry.
• Discover how to access the tools required to effectively implement corrective action to routine problems.
• Stop putting out fires and learn to extinguish the source.
• Understand why regulatory agencies added the "Preventive Action" clause to the requirements.
• Learn not only what is expected from your organization, but also how you can use it to impact the bottom line.

Topics

• What is CAPA?
• CAPA application
• Sources of quality data
• Methods of data analysis
• CAPA implementation
• Implementation effectiveness
• Medical device reporting
• Corrections and removals
• Medical device tracking
• Communication

Who Should Attend

Recommended for company owners and presidents, and management representatives, as well as staff in:

• Compliance/regulatory affairs
• QA/QC
• Manufacturing operations
• CAPA management
• Information systems/technology
• Document management
• Validation and auditing
• Engineering
• Design control

CEUs: 1.5
Number of Days: 2