Corporate Banner
Satellite Banner
Mass Spectrometry
Scientific Community
Become a Member | Sign in
Home>Events>This Event
  Events - October 2012

QbD Lifecycle Management for Analytical Methods

25 Oct 2012 - 26 Oct 2012 - London, UK

Bookmark and Share

A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method “incidents” when used in the routine environment. As the industry is moving towards applying Quality by Design (QbD) to process development - Is this also the way forward to improve and standardise our approach to method qualification?

This two day training course presents a brief overview of method validation according to ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to failure of methods with regards to method transfer and generation of OOS results later in the method lifecycle. It then introduces the concept of QbD in relation to analytical methods and focuses on the application of a three stage approach of QbD and lifecycle management. Finally a comparison of the current approach (ICHQ2) and the QbD approach is presented.

The course focuses on HPLC methods; therefore experience in developing, validating and transferring analytical HPLC methods would be an advantage to participants. The material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises.

Course objectives
This course is designed to provide training in how to apply Quality by Design and lifecycle
management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach.
Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. The course emphasises practical issues such as:
• Comparison of the traditional approach and QbD/lifecycle approach to analytical methods
• Applying the QbD and lifecycle approach to development and qualification of analytical methods
• Exploring and controlling variables of analytical methods
This course will deliver the tools to enable you to:
• Consider a QbD and lifecycle management approach to analytical methods
• Define an Analytical Target Profile
• Recognise the importance of understanding method variables of individual methods
• Develop more robust analytical methods
Who should attend
This 2 day course is valuable for Managers, Supervisors, Laboratory Analysts and Associates
involved in the development, validation, transfer or review of analytical methods in the Pharmaceutical and related industries with daily responsibilities in the following areas:
• Quality Assurance
• Quality Control Laboratory
• Regulatory Affairs
• Contract Laboratory
• Analytical Development Laboratory
• Training

Further information
Scientific News
Newly Identified Biochemical Pathway Could Be Target for Insulin Control
Researchers at Duke Medicine and the University of Alberta are reporting the identification of a new biochemical pathway to control insulin secretion from islet beta cells in the pancreas, establishing a potential target for insulin control.
Dirty,Crusty Meals Fit for (Long-Dormant) Microbes
Researchers apply the latest analytical techniques to further our understanding of desert biocrusts.
CSI -- On The Metabolite's Trail
Bioinformaticians at the University of Jena make the most efficient search engine for molecular structures available online.
First Complete Structural Study Of A Pegylated Protein
Significant data obtained at NUI Galway reports first crystal structure of a protein modified with a single PEG chain.
Potential Ovarian Cancer Biomarker Isolated
Researchers from North Carolina State University utilized a highly sensitive mass spectrometry analysis to identify and measure difficult-to-detect N-glycan biomarkers associated with ovarian cancers in stages I – IV.
Waters’ Centers of Innovation Program Honors Ohio State University Laboratory
Wysocki-led facility recognized for proteomics, disease research and mass spectrometry excellence.
Protein Aggregation After Heat Shock Is An Organized, Reversible Response
New study finds protein aggregation after heat exposure is a reversible cellular process, not unrecoverable damage from misfolding.
World’s Largest Protein Interaction Map Created
A multinational team of scientists sifted through cells of vastly different organisms – from amoebae to worms to mice to humans – to reveal how proteins fit together to build different cells and bodies.
Evidence of Ancient Life Discovered Deep Below the Seafloor
Ancient rocks harbored microbial life deep below the seafloor, reports a team of scientists from the Woods Hole Oceanographic Institution (WHOI), Virginia Tech, and the University of Bremen.
Structural Discoveries Could Aid in Better Drug Design
Scientists have uncovered the structural details of how some proteins interact to turn two different signals into a single integrated output.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos