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
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Unidentified Spectra Detector
New algorithm clusters over 250 million spectra for analysis, such that millions of unidentified peptide sequences can be recognised.
Making Metabolite Identification More Efficient
Metasense combines the industry's most-comprehensive metabolic transformation prediction with efficient analysis of LC/MS analytical measurements to identify, visualize, and report chemical biotransformations.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
A New Tool Brings Personalized Medicine Closer
Scientists from EPFL and ETHZ have developed a powerful tool for exploring and determining the inherent biological differences between individuals, which overcomes a major hurdle for personalized medicine.
Rapid Retrieval of Live, Infectious Pathogens from Clinical Samples
An engineered pathogen-binding protein enables rapid isolation of infectious bacteria from joint fluids and accelerates their identification.
Getting a Better Look at How HIV Infects and Takes Over its Host Cells
A new approach, developed by a team of researchers led by The Rockefeller University and The Aaron Diamond AIDS Research Center (ADARC), offers an unprecedented view of how a virus infects and appropriates a host cell, step by step.
Detecting Fake Parmesan Cheeses
Scientists report on a way to catch adulteration of the regional artisanal products.
The Need for Speed
Evaluating MALDI-TOF as a high-throughput screening technology for the pharmaceutical industry.
Process Analysis in Real Time
With a real-time mass spectrometer developed by Fraunhofer researchers, it has become possible for the first time to analyze up to 30 components simultaneously from the gas phase and a liquid, including in-situ analysis.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!