Corporate Banner
Satellite Banner
RNAi
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.


Overview

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

9.15am

  • 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
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Blood Test for The Earlier Diagnosis of Breast Cancer Spread
Researchers at University of Westminster have confirmed that a new blood test can detect if breast cancer has spread to other parts of the body.
First Gene Therapy Successful Against Human Aging
American woman gets biologically younger after gene therapies.
Targeting an ‘Undruggable’ Cancer Gene
RAS genes are mutated in more than 30 percent of human cancers and represent one of the most sought-after cancer targets for drug developers.
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Improving Engineered T-Cell Cancer Treatment
Purdue University researchers may have figured out a way to call off a cancer cell assassin that sometimes goes rogue and assign it a larger tumor-specific "hit list."
Uncovering How Some Breast Cancers Resist Treatment
A targeted therapy for triple-negative breast cancer (TNBC), the most aggressive form of breast cancer, has shown potential promise in a recently published study.
Characterizing Cancerous Genomic Variations
Tested on large tumor genomics database, REVEALER method allows researchers to connect genomics to cell function.
Activating Cancer-Killing Immune Cells
A UCL research team have discovered that cutting off a sleep-switch on immune cells inside a tumour wakes up the cells and enables the immune system to hunt down and destroy cancer.
Scroll Up
Scroll Down
SELECTBIO

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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!