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Training Program

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