Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
Become a Member | Sign in
Home>Events>This Event
  Events - June 2013

QbD Lifecycle Management for Analytical Methods

20 Jun 2013 - 21 Jun 2013 - Edinburgh, 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 now applying Quality by Design (QbD) to process development, it is now being recognized that this is also the way forward to improve and standardise our approach to analytical procedures.

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 illustrates that the lifecycle approach is a holistic process which embraces the philosophies of the traditional approach but results in more robust analytical procedures. 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.


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

Course Programme

Questions and answers will be taken throughout the duration of the course.

Day 1

8.45 am Registration and Coffee


  • Introduction
  • Traditional approach to validation (ICHQ2)
  • Exercise
  • The limitations of this approach

10.45am Morning refreshments

11.00 am to 12.30pm

  • Discussion of current approach (Groups share experiences of method problems)
  • Definition of QbD
  • Overview of ICH Q8, Q9 and Q10
  • Applying QbD to analytical methods (The three stages)

12.30 pm Lunch

1.30 pm to 3.00 pm

Stage 1

  • Gather Knowledge
  • The Analytical Target Profile
  • Exercise

3.00 pm Afternoon refreshments

3.15 pm to 5.00pm

Method design and Method Understanding

  • Risk assessment (exercise)
  • Understanding and controlling variables (Robustness and Ruggedness)

Day 2

9.00 am to 10.15 am

  • Robustness study
  • Design of experiments

10.15 am Morning refreshments

10.30 am to 12.00 pm

  • Ruggedness study
  • Conclusion of Stage 1

12.00 pm Lunch

1.00 pm - 2.30 pm Stage 2 - Procedure Performance Qualification

2.30 pm Afternoon refreshments

2.45 pm to 4.30 pm

Stage 3 - The lifecycle approach

  • Continued method verification
  • Quality systems - Change control and trending
  • How can the QbD approach to translate to less method transfer failures"
  • Overview Comparison of Traditional and QbD approach
  • Advantages of QbD

4.30 pm End of course

Further information
Scientific News
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
Inroads Against Leukemia
Potential for halting disease in molecule isolated from sea sponges.
Molecular ‘Kiss Of Death’ Flags Pathogens For Destruction
Researchers have discovered that our bodies mark pathogen-containing vacuoles for destruction by using a molecule called ubiquitin, commonly known as the "kiss of death."
A New Single-Molecule Tool to Observe Enzymes at Work
A team of scientists at the University of Washington and the biotechnology company Illumina have created an innovative tool to directly detect the delicate, single-molecule interactions between DNA and enzymatic proteins.
Milestone Single-Biomolecule Imaging Technique May Advance Drug Design
The first nanometer resolved image of individual tobacco mosaic virions shows the potential of low-energy electron holography for imaging biomolecules at a single particle level; a milestone in structural biology and a potential new tool for drug design.
Multi-Gene Test Enables Some Breast Cancer Patients to Safely Avoid Chemotherapy
A major study is providing the best evidence to date that a 21-gene test done on the tumor can identify breast cancer patients who can safely avoid chemotherapy.
Antidepressants Plus Blood-Thinners Slow Down Brain Cancer
EPFL scientists have found that combining antidepressants with anticoagulants slows down brain tumors (gliomas) in mice.
Diagnostics Breakthrough Brings Viral Sequencing to Doctors’ Toolkit
New screening tool produces up to 10,000-fold improvement in viral matches compared with traditional high-throughput methods.
New Virus Identified In Blood Supply
Scientists have discovered a new virus that can be transmitted through the blood supply.
Scroll Up
Scroll Down

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