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3-Hour Virtual Seminar on Analytical Method Validation Process

Compliance Key INC - Online HIPAA Training for Employees

                                                 Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. 
 Webinar Id: LSHCAB004
 10:00 AM PT | 01:00 PM ET
 11/02/2017
  Duration 180 mins 
Overview
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods
Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be used with samples that are typically encountered
This webinar will explain the validation of analytical procedures for determining the suitability of a given methodology for providing useful analytical data.
Why should you attend this webinar?
Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity, and potency of the drug substances and drug or other products.
In this webinar, you will learn:
  • Process to validate method
  • Components of method validation
  • Regulations USP / ICH / FDA
  • How we know what FDA is looking for
  • How to use Quality by Design (QbD) to enhance Analytical Method Validation
Areas Covered in the Session:
  • Method Development, Optimization and Validation Approaches
  • Method Validation - High Level
  • System Suitability
  • Validation Components
    • Accuracy
    • Precision
    • Repeatability
    • Interm. Prec.
    • Specificity
    • LOD LOQ
    • Linearity
    • Range
  • LifeCycle Concept
  • Validation Planning
  • Method Validation Protocol
  • Method Transfer & Revalidation
  • European and International regulatory bodies and their guidelines on different aspects of Method Validation QA
  • Quality by Design 
    • Lifecycle management of analytical procedures: development, validation, and routine use
    • Using principles of Quality by Design to get most robust methods
    • Defining validation parameters, acceptance criteria, and test procedures 
    • Templates and examples for efficient and consistent documentations
  • How we know what FDA is looking for
    • FDA Systems Based Inspection: Laboratory System
    • FDA 483s
    • FDA Warning Letters
Who can Benefit:
  • Any companies that have a laboratory or manufacturing operation
  • E.g. Merck
  • Pfizer
  • Food Companies
  • Academia
  • Agricultural
  • Tobacco
  • Veterinary
  • CLIA laboratories
  • CAP accredited laboratories
  • Genomic testing laboratories
  • Etc.

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Location: United States

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