Corporate Banner
Satellite Banner
Pharma Outsourcing
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
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos