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| INSTRUMENTAL TECHNIQUE |
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| COURSE : C-105 |
Duration : |
40 hours |
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Qualification : |
Minimum12th Grade |
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This course provide in detail idea of Pharmaceutical industries regulation and instrumental techniques. |
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| OSHA safety training: |
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| Safety course covers basic training for the handling of dangerous chemicals and spill control. Safety related plant evaluation and periodic inspection techniques. How to work with the poisonous chemicals in the laboratory. Video presentation for job related injuries and medical emergency. |
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| cGMP training: |
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| cGMP training to the chemist for the ongoing manufacturing and testing laws for FDA concern. Issues related to laboratory data and documentation according to FDA new guidelines. |
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| 21 CFR Part 210, 211 and 11: |
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| Basic understanding of CFR part 210, 211 and 11 from purchase to production to marketing of the drug products. 483 and other violations and corrective action plan to meet with the FDA regulations. |
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| Instrumentation and wet chemistry: |
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| Basic instruments such as Dissolution, disintegration, friability, hardness, thickness, tap density, UV-Vis., FTIR, KF Titration, AAS and TLC. Wet chemistry and analytical techniques. |
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| SOP writing: |
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| Develop the SOP writing skills for the pharmaceutical industry. Review the old SOP’s and update with current FDA standards. Write new SOP’s for laboratory and production department. |
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| Basic LIMS: |
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| Laboratory Information Management System is the computer based data management system where drug product manufacturing and analysis data can archives for future reference purposes. Basic idea can give high light of the computer-based techniques. Training for instrument connection, data transmittance and calculation using LIMS. |
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| Personal Skill: |
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| Interview preparation and resume preparation. |
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