Training

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I.                   Overall Pharma (Quality Control)  Laboratory Training :  [Theory ,Hands on Practials, Interview Orient Material , Certificate] – 40 Days

1.      Pharmaceutical industry over view & Introduction to Quality control Laboratory  

2.      General lab equipments

3.      Introduction to analysis                                 

4.      Good Laboratory Practice

5.      Laboratory safety                                           

6.      Loss on Drying

7.      Conductivity meter                                        

8.      PH meter

9.      Melting point apparatus                                 

10.  KF Titrator     

11.  Introduction to spectroscopy             

12.  Ultraviolet-visible spectroscopy

13.  Chromatography Introduction            - Paper, TLC & Column                                                        

14.   HPLC - Instrumentation, Operation, Calibration, Maintenance, Trouble shooting

15.  Method development & Validation (Theory)

16.  We can provide Academic Projects for M.Sc and B.Pharmacy,M.Pharmacy students

17.  Handling Wet analysis and Preparation and measurement of  Volumetric Solutions.

18.  Introduction to Stability Studies and Its Importance of various drugs.

19.  SOP & STP preparation

20.  Basics of cGLP/cGMP.

21.  Understanding various pharmacopeia requirements.

22.  Handling of Data and Audits

23.  Glossary         

24.  Resume preparation

25.   Mock Interview and Personality development.
(The Pharmaceutical Quality Control Analyst Certificate is awarded upon successful completion.
At the beginning of the course give the Course Material.)

                                                        

II.                HPLC & UV  with hand on practice:  [Theory ,Hands on Practials, Interview Orient Material , Certificate] – 10 Days

1.       Instrumentation & Operation

2.      Calibration & Maintainance

3.      Trouble shooting  & System Suitability Parameters

4.      Method Development & Validation (Theory)

 

 

III.             Analytical Method Development & Validation by HPLC & GC (Theory): [Theory , Interview Orient Material , Certificate] – 10 Days

1.      Concept of Method development

2.      Method development by HPLC

3.      Method development by GC

4.      ICH Guidelines

5.      Assay , Dissolution, Content Uniformity & Related substances Validation

6.      Cleaning Validation

7.      Preparation of Protocol & Report

8.      Method validation by HPLC

9.      Method validation by GC

10.  Interview based training

                                        

II.        Quality Assurance Basic Training & Documentation –  [Theory, Interview Orient Material , Certificate] – 15 Days

1.      Quality Assurance General Concept & Responsibility

2.      Validation and Qualification

3.      Preparation Maintenance and Distribution of Documents (Standard Operating Procedures, Standard Testing Procedures, General Testing Procedures , BMR-Batch Manufacturing Records and Specification)

4.      Overview & Importance applications of the Following Guidelines (GMP, GLP, ICH & CFR etc.)

5.      Good documentation practices & Classification of Documents 

6.      Drug Master Files (DMF)

7.      Understanding of analytical methods, procedures and implementation in manufacturing sites from QC perspective

8.      Handling of out of specifications 

9.      Understanding various pharmacopeia requirements.

10.  Handling of Data and Audits