Documenting & Conducting CAPA Investigations

Accurate and thorough documentation and a process for conducting investigations is critical in an FDA-regulated environment. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds.

This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations. It integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations. This training is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems – such as engineers, investigators, laboratory QA, manufacturing supervisors and technicians.

Areas Covered in the seminar:

• Effectively expedite investigations.
• Document investigations appropriately for the intended audience.
• Assure that all necessary data/information is collected and documented.
• Overlay the FDA’s requirements and expectations related to conducting and documenting investigations.
• Construct an effective report.
• Attain a thorough understanding of the FDA’s requirements and expectations related to conducting and documenting investigations.
• Prepare clear, concise and effective documentation of investigations.
• Improve communication and teamwork.

Who will benefit:

This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems.

• Engineers
• Investigators
• Laboratory QA
• Manufacturing Supervisors
• Technicians

Instructor Profile:
Nathan Conover, has spent nearly a decade working with the Medical Device, and the Life Science Industry. His main focus has been around managing world-wide integrations of risk and corrective/preventive action systems, procedures, process, and skills. Nathan has completed global rollouts with many of the Fortune 500 companies in the Life Science Industry. Over the past five years, much of Nathan’s time has been spent in the European Life Science Community, working with both life science companies and regulatory investigators. This experience has given him a broad insight into many different markets, cultures, and regulated environments, that helps PathWise tackle many of the challenges associated with the globalization of the industry. He regularly presents and consults with large to medium size organizations around the world on how to improve quality and how to stay in compliance with FDA and ISO standards and regulations.

He is a faculty member of the Parental Drug Association (PDA), American Association of Medical Instrumentation (AAMI), and IVT. He earned his Bachelor’s degree in Science from the University of Utah, received an MBA from The George Washington University, and is a Certified Leadership Coach. He is currently pursuing a Masters Degree in Biotechnology from Georgetown University.

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