Product Development & Analytical Course - 1
COURSE CONTENT
1] Instrumentation - Instrumentation, Operations, Calibration and Troubleshooting.
High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-VIS Spectrophotometer, Karl-Fischer, pH Meter, Particle Size analysis, Analytical Balance, Brookfield Viscometer. Introduction to TGA, DTA, DSC, LCMS, GCMS, NMR and IR
2] FDA Guidance on
cGMP, GDP, GLP, NDA, IND, ANDA, Regulatory - Product Filing, CTD format, ANDA Module 1-5, Deficiency response, Proof-of-Concept, Report Writing, ICH Guidelines 
 
3] Product Development
Synthesis and Formulation, Formulation and Analytical Development and Validation, Quality control and Quality Assurance, MBR, In-Process Control, Critical Quality Attributes, Critical Process Parameter, Quality Targeted Product Profile, Stability, Packaging Evaluation, Impurity Profiling, Toxicity Study
4]Patent Reviewing
Learn to read and understand patent reading, writing and reviewing
 
Why Do This Training ?
For those looking for JOB'S in Pharmaceutical and Chemical Industries

  • Experience with Sophisticated Instrument
  • Experience the Corporate culture
  • Develop Analytical Skills and Thinking
  • Develop Formulation Skills and Thinking
  • Develop Documentation practice
  • Develop Reading and Writing Skills
  • Pharma Networking
  • Gain Confidence for Interview cracking