Live Webinar Analytical Methods Validation for FDA Compliance

12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

Learn How to use Quality by Design (QbD) to enhance Analytical Method Validation


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 useful 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 -

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

1)    Method Development, Optimization and Validation Approaches
2)    Method Validation – High Level
3)    System Suitability
4)    Validation Components
      a)    Accuracy
      b)    Precision
      c)    Repeatability
      d)    Interm. Prec.
      e)    Specificity
      f)    LOD
      g)    LOQ
      h)    Linearity
      i)    Range
5)    LifeCycle Concept
6)    Validation Planning
7)    Method Validation Protocol
8)    Method Transfer & Revalidation
9)    European and International regulatory bodies and their guidelines on different aspects of Method Validation QA
10)   Quality by Design
      a)    Lifecycle management of analytical procedures: development, validation and routine use
      b)    Using principles of Quality by Design to get most robust methods
      c)    Defining validation parameters, acceptance criteria and test procedures
      d)    Templates and examples for efficient and consistent documentations
11)   How we know what FDA is looking for
      a)    FDA Systems Based Inspection: Laboratory System
      b)    FDA 483s
      c)    FDA Warning Letters

Who will Benefit

•    Anyone in a laboratory setting that needs to validate methods
     •   Chemists (research and quality control personnel) involved in analytical method development, validation or transfer
     •   Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
     •   Laboratory managers and staff
     •   Analysts
     •   QA/QCU managers and personnel
     •   Training department
     •   Documentation department
     •   Consultants

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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