Curriculum
- 5 Sections
- 28 Lessons
- 16 Weeks
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- UNIT-I8
- 1.1Overview of Life Sciences industry in Indian and global context.
- 1.2Industrial Practices like Standard Operating Procedure (SOP), GMP, GLP, 21CFR and ALCOA Plus guidelines relevant to Analyst/Chemist-Quality Control.
- 1.3Impact of Non-compliance on the quality of the product.
- 1.4Discuss workplace hazards and their reporting in the laboratory and manufacturing facility as per 5S system in the life sciences sector.
- 1.5Explain different types of breaches in the environment, health, safety and security.
- 1.6Effectively communicate and collaborate with manager and colleagues for multiple scenarios.
- 1.7Discuss how to respond to auditors with integrity.
- 1.8Discuss the rules laid by the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act and the provided penalties for violation.
- UNIT-II4
- 2.1Pipetting and Micro pipetting techniques.
- 2.2Properties and Safe handling of standards, solvents, reagents, hazardous chemicals and their storage as per Hazard Classification.
- 2.3Steps to prepare and standardize volumetric solutions and test solutions.
- 2.4Types of tests performed in quality control lab in various formulations, Active Pharmaceutical Ingredient (API) and packaging material.
- UNIT-III4
- 3.1Various statistical concepts used in laboratory investigation and Pre-analysis.
- 3.2Calibration and accuracy test for lab instruments.
- 3.3Standardization, validation related documentation and e-Lab Note Book (eLNB) for documenting experiments and analysis reports.
- 3.4Concepts of Corrective Action and Preventive Action (CAPA) and change control.
- UNIT-IV7
- 4.1Properties of different chemicals, reagents and reference standards and working standards used for HPLC analysis.
- 4.2Safety measures to be taken while operating the HPLC instrument.
- 4.3Method Development & Method Validation Procedures for HPLC
- 4.4Sample preparation Procedure for HPLC analysis in light of stability and storage requirement.
- 4.5Analytical calculations required in a HPLC analysis
- 4.6Methods of recording and analysis of HPLC chromatogram.
- 4.7Concepts of HPLC data deviations in case of deviations in the results.
- UNIT-V5
- 5.1Properties of different chemicals, reagents and standard solutions used for Ultraviolet (UV) – visible spectroscopy analysis.
- 5.2Recall the safety measure to be taken while handling Ultraviolet (UV) – visible spectroscopy.
- 5.3Discuss the procedures of sample preparation for Ultraviolet (UV) – visible spectroscopy analysis.
- 5.4Troubleshooting and Calibrate Ultraviolet (UV) – visible spectroscopy machine.
- 5.5Explain methods of recording and analysis of UV- visible spectroscopy test results.
Industrial Practices like Standard Operating Procedure (SOP), GMP, GLP, 21CFR and ALCOA Plus guidelines relevant to Analyst/Chemist-Quality Control.
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