EDGE: Pharma QC School

Giving you the EDGE of KNOWLEDGE

Course Overview

This two-day course will focus on factors to be considered in the logical and informed method development which leads to high quality, reproducible and robust HPLC methods. The course introduces the wide array of equipment and chemistry choices available to method developers in the modern analytical laboratory and teaches a refined and logical approach to method development. Awareness sessions on how modern laboratory instruments and data management can assure technical compliance with data integrity requirements.

Learning Objectives

By attending this training, you will gain:

  • Regulatory focus on data integrity co-relating to QC workflow.
  • Hands-on experience and theoretical knowledge in the areas of instrumental analysis.
  • Expand your knowledge on regulatory compliances.
  • Platform to connect with industrial experts / Pharma professional
This will assist the companies to reduce human errors, loss of time in analysis, as well as
audits and thereby improve the laboratory productivity.
Who should attend?
  • QC Chemists, QA Personnel, Scientists
  • Fresh Graduates & Post graduates in the field of Chemistry, Biochemistry, Life Science & Pharmacy
What will you receive?
  • A copy of the course materials
  • Certificate of participation
  • Fees include lunch & refreshments
    during course period
Registration Fees
  1. Industry participants
    Rs. 12,000 /- plus taxes
  2. Academia participants
    Rs. 10,000 /- plus taxes
Tailored to specific requirements
  1. Courses & training materials are modular
  2. Training can also be adapted to reflect the existing skills of attendees
  3. Training is divided into different levels so that participants can take the course most appropriate for their required skill level
Course Schedule and Program
Day 1
  1. Sample Preparation – Selection & Use of syringe filters
  2. HPLC Analytical Method Development – Chromatographic parameters/
    HPLC column selection/Mobile phase selection/
    pH of the mobile phase and pKa of the analyte/
    Isocratic or Gradient elution -systematic approach
  3. Effective HPLC Troubleshooting – To discuss the sources of
    top 5 HPLC problems and problem solving approach
  4. Hands on training on HPLC instrument – Role of HPLC column / Mobile phase and
    eluent pH instrumental parameters in development of Analytical Method
Day 2
  1. Introduction to code of Federal Regulations & important CFR guidelines
  2. FDA 483’s – Form 483 and FAQs
  3. Good Laboratory Practices and Safety
  4. Impact of water quality on Analytical Results
  5. Mitigating Data integrity challenges through digital data management
  6. Pharmaceutical Secondary Standards – FDA Regulation and Guidelines
Other Related Schools:
  1. EDGE – Microbiology Pharma School
  2. EDGE – Microbiology Food and Beverage School