A system needs to be fully qualified to produce high-quality products in a consistent manner. Therefore Equipment Validation is of utmost importance. Equipment Validation comprises a series of system qualifications, such as Design, Installation, Operational, and Performance Qualification, that provide a high degree of assurance of the consistent, expected functioning of equipment.
This program will cover Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) or Continuous Qualification (CQ), Qualification Protocol Test Case Examples, Power off / Power failure tests, Door Open tests, Alarm testing, Loaded and Empty Mappings, Instrument/equipment calibration.
Guidelines and Standards
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ) or Continuous Qualification (CQ)
Qualification Protocol Test Case Examples
Power off / Power failure tests
Door Open tests
Temperature Distribution tests
Temperature Penetration tests
Loaded and Empty Mappings
Instrument / Equipment calibration
Shelf mapping, vacuum testing, biological indicator test, Bowie Dick test, vacuum leak test, conductivity tests, riboflavin removal testing, controlled rate mapping
Qualification and Validation Service Reports, Protocols and SOPs
After successful completion of this course, students will be :
Anyone who wants to become the following should attend this webinar on equipment validation in the pharmaceutical industry.
– 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.