About the Course
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GMP of Parenteral and Sterile preparation
Introduction to GMP and Regulatory Guidelines
Facility Design and Layout for GMP
Documentation and Record Keeping
Stability Studies
Non Compliances Observed in Parenteral and Sterile Preparation
Process Validation
Media fill Validation
Recent Advancements in Analytical Instrumentation Techniques
Validation of Lyophilizer
CIP SIP of Simple and Complex Injections
Pharmaceutical water system and qualification
Concepts of OOS, Deviation
Primary Packaging Material for parenteral and Sterile preparations
HVAC System for parenteral & Sterile Prepration
Planning Conducting inspections based on risk based approach
Validation of Sterilization process
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Post Assessment
Assessment
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Certificate
CDSCO Certificate
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