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.


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
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Scroll Up
Scroll Down
SELECTBIO

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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!