In this training, we will address non-conformance report (NCR), CAPA and problem report (PR) writing. We will cover thorough root cause analysis writing and demonstrate how to write clear investigations that flow, identify real root cause(s), implement effective corrective/preventative actions, and justify, prove and defend decisions. You will also learn how to write clear and concise justification letters that support RCA and CFR to explain, prove and defend your decisions.
What reports must be written during the RCA process?
Non-Conformance Reports (NCRs)
CAPA and Problem Report (PR) Writing: Thorough Root Cause Analysis
This course is intended for anyone from:
Vijay Bachus - Vijay Bachus offers subject matter expertise in cGMP compliance related to 21 CFR Parts 111 and 117 to NSF Health Sciences. He is experienced in guiding top industry leaders through strategic growth and catapulting business owners to success. Vijay specializes in facility and business operations compliance. He holds a Bachelor of Science in molecular, cellular and developmental biology from the University of Colorado.