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.
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
1) Method Development, Optimization and Validation Approaches
2) Method Validation – High Level
3) System Suitability
4) Validation Components
d) Interm. Prec.
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
• Anyone in a laboratory setting that needs to validate methods
• Any companies that have a laboratory or manufacturing operation
• E.g. Merck
• Food Companies
• CLIA laboratories
• CAP accredited laboratories
• Genomic testing laboratories
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.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.