Documenting & Conducting CAPA Investigations (701038LIVE)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Sep 30, 2008
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Description

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

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 course provides a process to overcome that challenge. Documenting and Conducting CAPA Investigations integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations.

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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