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.

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