Training Program – iSERA

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Quality management Systems and Microbial testing in Pharma and Biopharma industries

Module No	Topic	Scope
M0	Overview of Pharmaceutical /Biotech /Manufacturing Industries Good Manufacturing Practices / Good Laboratory Practices/ good doccumentation practices Introduction to URS, IQ,OQ, PQ concepts / Facility Qualification / Calibration Qualification (IQ,OQ and PQ of Instruments) Introduction to Quality Management Systems- Change Control, Déviation, OOS, CAPA Introduction Regulatory Bodies , Internal and External audits Introduction to Monograph Development and General Notices	Theory Demonstration Industry Visit
M1	Introduction to Sampling Practices,Good Weighing Practices, good Pipeting Practices Media Preperation and Sterilization Growth Promotion Test Microbial Culture Maintenance Biohazardous Waste Management Disinfectant Preperation and Validation Laboratory Inventory Management	Theory Demonstration Practical Industry Visit
M2	Microbial Limit Test BioBurden testing Pharmaceutical Water Testing Packaging Material Testing Environmental Monitoring and Trend analysis Personal Monitoring Utility Monitoring Sterility Testing Bacterial Endotoxin Testing AntiBiotic Assay Preservative Efficacy Test	Theory Demonstration Practical Industry Visit

Bioprocess techniques , bioanalytical testing and bioassay in Biopharma Industry

Module No	Topic	Scope
B1	protein purification SDS PAGE Analysis Protein Estimation ELISA Immuno Diffusion and Immuno Precipitation Assays Immuno Electrophoresis	Theory Demonstration Practical Industry Visit
B2	Animal Cell Culture Media Preperation & Sterilization Dencity gradiant centrifigation Animal Cell Culture Cell Viability Assay Cytotoxic Assay Laboratory Animal Handling	Theory Demonstration Practical Industry Visit
B3	ED50 and LD50 Analysis Abnormal Toxicity Test PK Studies Pyrogen Testing	Theory Demonstration Practical Industry Visit

Cosmetic Science

Module No	Topic	Scope
CS1	Basics in Formulation Chemistry Cosmetics and personal care raw materials Common delivery systems for Topical products Preservative Selection for each system Sensory Evaluation Characteristics Evaluated Types of Sensory testing Manufacturing ( Batching & Mixing) Hair Care, Skin Care, Household Care product prototype Preperation Stability Studies Emulsion Stability Finished product Stability Prediction of Shelf life	Theory Demonstration Practical Industry Visit