Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements 2010

This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

Why Should You Attend :
Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf-life. The majority of analytical methods used in pharmaceutical development are HPLC analyses. cGMPs require validated stability indicating methods used to monitor the drug product s stability profiles.

This interactive 4 hrs long course will examine validation parameters for HPLC methods used in pharmaceutical laboratories based on cGMP regulations and ICH guidelines. It will discuss proved forced degradation strategies to develop stability-indicating analytical procedures. Learn effective way to write validation protocol and determine acceptance criteria for validation, make documentation more manageable. This course will provide a practical and systematic approach to validate analytical procedures.

Areas Covered in the Seminar:

• Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins)
  • Drug Development Process
  • cGMP requirements for analytical test methods
  • Review ICH Q2 A&B guidelines for method development/validation
• Module II Development and Validation Stability Indicating Methods ( 35 mins)
  • Design method specificity through forced degradation activities
  • Discuss validation characteristics
• Module III. Designing Method Validation Protocols ( 35 mins)
  • Establish Method Validation Protocol
  • Establish Method Validation Protocol
• Module IV. Managing Validation Data for Quality and Compliance ( 55 mins)
  • Design Phase-appropriate method validation
  • Handling validation failure

Time Schedule:

Duration : 3.5 hours of instruction, 15 min breaks as they fit into the schedule

(All times in Eastern Standard Time)

• 1:00 PM EST - 1:40 PM EST - Module 1
• 1:40 PM EST -- 2:15 PM EST - Module 2
• 2:15 PM EST -- 2:30 PM EST Q/A of Module 1&2
• 2:30 PM EST - 2:45 PM EST - Break
• 2:45 PM EST - 3:20 PM EST - Module 3
• 3:20 PM EST - 4:15 PM EST - Module 4
• 4:15 PM EST 4:30 PM EST Q/A of Module 3&4

Who Will Benefit:

This course will benefit R&D analysts, QA and QC Managers, Regulatory scientists, Directors, Regulators and Researchers who are responsible for providing analytical data pertaining to pharmaceutical products. To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.