2 Day Seminar on “Death by CAPA – Does your CAPA Program need a CAPA?” – GlobalCompliancePanel

If there is a really solid edifice on which a strong Quality Management System (QMS) rests, it has to be Corrective and Preventive Action (CAPA). This is because a QMS can never guarantee safe and effective products without CAPA. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters.

An inefficiently conceived and implemented CAPA system means time and resources going down the drain. The criticality that CAPA has to a QMS can be gauged from the fact that it is one of the primary reasons for which the FDA issues 483’s and Warning Letters.

All these point to the need for the establishment of a solid CAPA process that is built into the QMS. An organization should ensure that it establishes a compliant, effective, and efficient process. Yet, despite the all-powerful importance that CAPA has for the medical device industry, many manufacturers in this area have difficulties in establishing and maintaining an effective CAPA process.

How do organizations overcome this problem? A two-day seminar, entitled “Death by CAPA – Does your CAPA Program need a CAPA?” from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will provide the answers. At this in person, live seminar, which is being organized in Philadelphia, PA on October 24 and 25, Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., will be the Director.

Please join us for this highly valuable session by enrolling at This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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The learning offered at this seminar will help participants establish an efficient and effective CAPA process that leads to an improvement in quality and compliance. Participants will learn the ways of streamlining and monitoring their processes that will ensure compliance and improved performance.

Susanne will explain the regulatory requirements regarding CAPA in detail. She will sort out the various myths surrounding CAPA, as well as the challenges of managing CAPAs. This knowledge will help them prevent and overcome common problems and pitfalls. She will offer an explanation of some of the best practices in establishing a CAPA, the knowledge of which helps organizations insulate themselves against an FDA inspection.

Over the two days of this seminar, participants will hear detailed lectures on all the elements of a CAPA program. Susanne will explain the ways in which these elements connect to other parts of the organization’s Quality Management System. The Director will explain to participants ways by which they can create a CAPA program that results in:

• Improvement in product quality
• Reduction in compliance issues
• Advancement in their business success.

An additional benefit the participants will get is the set of tools and checklists which will help them to ensure that their program is ready to face an FDA inspection.

Susanne will cover the following areas at this seminar:

• Regulatory Requirements and expectations
• Elements for creating an efficient and effective CAPA Program
• CAPA process, tools, and techniques
• Linkages throughout the Quality Management System
• Root Cause Analysis
• Metrics, Control, and Monitoring
• Dissemination of Information
• Myths, Challenges, Best Practices
• Inspection Preparedness

This seminar is of immense value to professionals whose work is associated with the organization’s QMS. These include Quality Systems Specialists, Document Control Specialists, Quality and Compliance Specialists, Quality Engineers, Internal Auditors and Managers, Training Specialists, CAPA Specialists, CAPA Managers, Supplier Quality Engineers and Auditors, Quality/Compliance managers or directors for Medical Device companies, General Managers wanting to learn how to understand Quality System requirements, and Management Representatives.

Do You Know How to Identify Root Cause and How to Close Out Your Investigation?

Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program. Root Cause Analysis and CAPA are tied to each other intricately. This being the case, it is commonsensical to perform the two functions in tandem with each other applying the principles of risk management. This method makes business sense, as it saves time and cost. This requires companies that want to do an RCA in conjunction with CAPA to have complete knowledge of the principles of CAPA.

The lack of effectiveness of a company’s RCA is reflected in the inability of the CAPA to fulfill its purpose. An effective Quality Management System is unthinkable without CAPA. In the FDA’s thinking, a Quality System can go awry if effective CAPA is not in place.

So, a CAPA action plan rests on a sound Root Cause Analysis. Any organization that fails to implement this can expect recurring problems and issues. Some of them could turn out to be serious enough to derail their business.

Complete understanding of RCA and CAPA

All the learning Areas:

• Regulatory Expectations for Investigations
• What is RCA and Typical Problems
• Investigation Process Overview
• Skills and Tools of an Effective Investigator
• (Re) Introduction to Root Cause Analysis (RCA)

• Principles of root cause analysis
• Why root cause analysis is difficult
• Methodology of root cause analysis

STEP 1 – Problem Definition

• How to ensure that the right problem is being worked on
• Tools and filters for priority setting
• Developing a clear and sufficient problem statement (includes practice)

STEP 2 – Understanding the Process

• How every problem is a process failure
• How diagrams can set boundaries and define interrelationships
• Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 – Identifying Possible Causes

• Multiple ways to identify possible causes
• Options for selecting or eliminating causes
• Logic trees as a cause and effect diagram and other tools for investigations

• Defining the Deviation
• Identifying Root Cause
• Corrective and Preventive Actions (CAPA)
• What is the CAPA System
• Definition and regulatory interpretation
• Identifying and writing of corrective actions
• Abuses of the CAPA system
• Discuss robustness and effectiveness review
• Management of the Investigation
• Members of the Investigation Team
• Consulting Case Study Practice – Incident/Events
• Case Study Practice
• Interactive Exercises and Discussions.