Process Validation (PV) is a critical element in the pharmaceutical manufacturing process. Hence experts in this domain are in high demand.
This training program focuses on the practical application of the lifecycle approach to all stages of process performance qualification to gain appropriate levels of knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. The modules on this subject cover case studies from the pharmaceutical and biotechnology sectors.
Pharmaceutical Process Validation/Cannabis Process Performance
Process Performance Qualification Objectives
Process validation stages
Process validation approaches
Process validation components
Master Validation Plan
Process Validation Strategy
Preparing for Process Performance Qualification (PPQ)
Sampling plan and testing plan
Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement
Understand implications of validation deviations
Minimize the chance of validation failures
Acquire tools to prepare for a smooth validation execution
PPQ for Bulk Hold Time Studies
PPQ for Stability Studies
Case Study – Pharmaceutical Process
Case Study – Biotechnology Process
After successful completion of this course, students will be :
Anyone who wants to become the following should attend this webinar on pharma cleaning validation:
– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH
Rathi Param is the president/founder of 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. She is an innovative and creative leader with more than twenty years of hands-on experience in many scientific industries (medical cannabis, medical devices, environmental, food, pharmaceutical and bio-pharmaceutical), complemented with fifteen years of academic and corporate training experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Formulation, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing, and Inspection.