|
| PHARMACEUTICAL ANALYTCAL SCIENTIST / CHEMIST |
|
|
| |
|
|
| COURSE : IC-102 |
Duration : |
12 months |
| |
Qualification : |
BS |
|
| |
|
| |
| Module - 1(Basic): |
| |
The basic module is designed to provide students an in-depth knowledge of applied pharmaceutical sciences, bio-pharmaceutics, Chemical, and Regulatory affairs. Novel concepts in leading edge industrial pharmaceutical research, applied statistics and experimental design are a major component of the module.
This course includes principal, instrument operation and basic training for lab instruments. Laboratory testing of drug products and data reporting to the manager. Preparation of mobile phase, standard, samples solution and their instrumental analysis. Basic training for HPLC parts identification, operation techniques and trouble-shooting. Normal phase and reverse phase chromatographic techniques. Student can work as an entry level chemist after completion of this course and other prerequisite instrument techniques. |
| |
| |
|
| |
| Module – 2 (Intermediate): |
| |
This course covers training for HPLC instrument operation as well as GC instrument techniques. Analysis of certain drug product with one or more than one active ingredient. Use of internal standard in drug analysis. Lambert beer’s law. Use of light law in pharmaceutical industry. HPLC/GC trouble-shooting and column selection in analysis.
The intermediate module focuses on practical training in pharmaceutical experimental design, formulation technology and manufacturing techniques. Hands-on experience is acquired through team-based projects, in compliance with GMP and GLP, in our state-of-the-art research laboratories and manufacturing plant. Analytical techniques, problem solving, protocol and technical writing skills are acquired throughout the module. |
| |
|
| |
|
| |
| Module – 3 (Advanced): |
| |
The advanced module provides an opportunity to engage in independent method development, processes validation, method validation and research projects for ANDA.
Courses covers HPLC/GC analysis, method development and validation techniques in pharmaceutical industry. HPLC/GC trouble shooting in detail for peaks and their parameters that governs integration. HPLC parts identification and purchase from the vendors. Lamp change and instruments seal replacement. Basic idea for cleaning validation in CFR 21 part 210 and 211. FDA regulations in R&D department. |
|
 |
Drug analysis |
 |
Analytical instrumentation (HPLC, GC, Spectroscopy, AA, KF, Dissolution) |
 |
Documentation systems |
 |
Drug stability studies |
 |
Quality, compliance and auditing |
 |
Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) |
|
|
The advanced module provides an opportunity to engage in independent method development, processes validation, method validation and research projects.
Courses covers HPLC/GC analysis, method development and validation techniques in pharmaceutical industry. HPLC/GC trouble shooting in detail for peaks and their parameters that governs integration. HPLC parts identification and purchase from the vendors. Lamp change and instruments seal replacement. Basic idea for cleaning validation in CFR 21 part 210 and 211. FDA regulations in R&D department. |
| |
|
| |
|
| |
| Module – 4 (Internship): |
| |
Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty on one of the many unique projects undertaken at the Institute. |
|
| Top |
|
| |
|