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
Could a simple saliva test detect Alzheimer's?
Researchers have presented findings suggesting that a simple, non-invasive diagnostic for Alzheimer's could be within reach.
Facebook for the Proteome
Researchers have developed a network for describing protein-protein interactions that can then be used to examine protein interactions that may have biological or clinical significance.
Researchers Reveal Elusive Molecule
A long-standing chemistry puzzle has been solved, with potential implications ranging from industrial processes to atmospheric chemistry.
‘Atomic Detectives’ Scientists that Keep us Safe from Radioactive Criminality
Stephan Richter from the JRC-Institute for Reference Materials and Measurements has examined the merits and limitations of available mass spectrometric instrumentations for nuclear safeguards applications.
MSU Scientists Uncover a ‘Funky Cofactor’
While examining the chemical reactions of bacterial cells in a lab at Michigan State University, researchers found an unusually complex molecule in a protein that completes a simple process.
Aluminum Clusters Shut Down Molecular Fuel Factory
3-D images give clues to extending catalyst life.
Chemists Design a Quantum-Dot Spectrometer
New instrument is small enough to function within a smartphone, enabling portable light analysis.
Creating Bacterial ‘Fight Clubs’ to Discover New Drugs
Creating bacterial “fight clubs” is an effective way to find new drugs from natural sources.
Informatics Tool Helps Scientists Prioritize Protein Modification Research
Researchers have developed a new informatics technology that analyzes existing data repositories of protein modifications and 3D protein structures to help scientists identify and target research on "hotspots" most likely to be important for biological function.
Iron: A Biological Element?
Study shows findings which have meaning for fields as diverse as mining and the search for life in space.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!