Program 13: Post Graduate diploma in Quality Analysis and Quality Assurrance
Quality is an important factor when it comes to any product or service. With the high market competition, quality has become the market differentiator for almost all products and services. Many people get confused between quality control (QC) and quality assurance (QA).
- Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer.
- Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers
MODULE 1: Quality Control
- Introduction to chromatography and classification of chromatographic methods based on the mechanism of separation.
- Principles and procedures involved in the determination of the official compounds in IP with the following analytical techniques
- Diazotization methods
- A detailed study of the principles and procedures involved in the quantitative determination of the following organic functional groups
- Carbonyl compounds
- Hydroxyl and carboxyl
- Study on handling, principle and procedure for the calibration of the following instruments
- UV-Visible Spectrophotometer
- Gas Chromatography
- FT-IR Spectrometer
- Dissolution test apparatus
- Principle, instrumentation and applications of the following spectroscopic methods
- Raman Spectroscopy
- ESR (Electron Spin Resonance) Spectroscopy
- Quality control of bulk drugs and formulations
MODULE 2: Quality Assurance
- cGMP and Documentation
- Concepts of Quality Assurance, Total Quality Management, Philosophy of GMP and cGMP
- Concepts of Validation: Types of validation, Master plan, protocol for process validation, cleaning validation, validation of air handling, validation of equipment and facilities in sterile and non-sterileareas.
- Manufacturing documents, Master Formula, Batch Formula, Records, Standard Operating Procedures.
- Brief content on Intellectual property rights and Regulatory Affairs
Who should join?
If you are a B.Pharm, M.Pharm, M.S.Pharm, Pharm.D or B.Sc, M.Sc in Chemistry, Analysis, Quality control and Quality Assurance who is looking to strengthen concepts and build on hands-on skills, which would help you grab the right job, this is the right place to enroll.
The module consists of 60 days classroom training with our expert faculty followed by 30 days practical exposure with our service provider. Also avail our e-learner facility.
Total Duration: 90 days
The classes will be held in Biotecnika Bangalore branch/ Online.
Lab Partner: Azyme labs