Module 1
Process Validation guideline – FDA and Health Canada
Process Validation requirements: Eu-GMP, GMP, cGMP
Module 2
How to perform validation
Cannabis Process Validation/Cannabis Process Performance Qualification
Cannabis Packaging Validation
Cannabis Cleaning Validation
Cannabis Method Validation
Module 3
Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
Master Validation Plan
Module 4
Validation Protocol components
Process validation Strategy
Process description
Critical / non-critical parameters
Sampling plan and testing plan
Testing criteria
Acceptance criteria
Module 5
Validation Report
Case study and Q&A
After successful completion of this course, students will be able to:
– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH
Rathi Param is the president / founder of the NACPT Pharma College, International Medical Cannabis Association (IMCA), and Validation Tech Inc. Rathi earned her B.Sc. in Chemistry from University Ottawa, MBA in Technology from the University of Phoenix and Post Graduate Pharmaceutical QA & QC Certification from SRN Institute.