Root Cause Analysis: Investigative and Justification Writing for the Dietary Supplement Industry
About This Course
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.
Key Learning Objectives
What reports must be written during the RCA process?
Non-Conformance Reports (NCRs)
- Basic requirements of the cGMPs
- Deviations and unexpected occurrences
- Timeliness of reporting and investigations
CAPA and Problem Report (PR) Writing: Thorough Root Cause Analysis
- Root cause analysis (RCA) best practices
- Failure investigations for RCA
- Investigations of laboratory results
- Analyzing batch production records for RCA
- Review of logs, forms and other process documentation for RCA
- How to recognize when you have found the root cause(s)
Who Should Attend?
This course is intended for anyone from:
- Quality Control/Assurance
- Laboratory Operations
- Suppliers and Distributors
- Regulatory Affairs
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.