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All documents shown here are included in the seminar for instant download

 

 

The seminar material includes three forms related to Method Validation through QbDr

The seminar material also includes a Presentation with an update on the status the FDA's QbD initiative

 

QbD for Better Method Validation and Transfer (link)

Quality by Design Systematic Chromatographic Method Development

Attendees get access to FDA warning letters related related to inadequate  method validation

 

 

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 337

Impact of Quality by Design on the Analytical Laboratory  

Learn through the example from development and validation of analytical procedures

Recorded, available with all reference material at any time

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Even though the Quality-by-Design (QbD) principle is well known in the industry to improve the quality of data and efficiency of operations, it is a new concept for analytical laboratories. This is changing since regulatory agencies such as the US FDA and European counterparts are heavily promoting and supporting QbD. This presentation gives an overview of the principles and regulatory requirements. In addition we will discuss benefits for laboratories and clients, and we will go through the process and entire steps of QbD in laboratories using the “Development and Validation of Analytical Methods” as an example. Attendees will get a good understanding on what QbD is and how to implement if for laboratories..

Key Questions related to quality-by-design for laboratories:

  • What are the key applications of QbD for Analytical Laboratories
  • What are the advantages for the laboratories and customers?
  • What is the situation in the industry?
  • What is the process of analytical QbD
  • Are there examples for the analytical target profile (ATP)
  • Method design and development
  • How to define design space and method operational ranges
  • Is the validation different from ICH Q2?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • Introduction to analytical QbD
  • Industry initiatives for QbD in analytical laboratories
  • Applications of QbD for Analytical Laboratories
  • Traditional validation vs. QbD validation
  • Definitions: Analytical Target Profile (ATP), Critical Method Parameters (CMP),
    Critical Method Attributes (CMA), Method Operational Design Range (MODR)
  • The 6-stage process of analytical QbD
  • Analytical target profile (ATP)
  • Method design and development
  • Sources of variability impacting critical method attributes
  • Risk assessment to determine critical method variables
  • Multivariate Design of Experiments (DoE)
  • Design space and method operational ranges
  • Validation / qualification
  • Control strategy
  • Continuous improvement
  • Advantages of QbD for laboratories, Industry concerns
  • EMA/FDA answers to frequently asked questions

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Master plan - Template and examples: Development and Validation of Analytical Methods through QbD
  • SOP: Development and Validation of Analytical Methods through Quality by Design
  • Templates
    - Analytical Target Profile for selected HPLC methods
    - Design space for selected HPLC methods
    - Risk Prioritization Matrix for Quality by Design based Method Validation
  • Five industry presentations and case studies related to
    - QbD for method development and validation
    - QbD for dissolution testing
  • Eight Reference Articles
    -
    QbD for Better Method Validation and Transfer (link)
    - A Quality by Design approach to investigate tablet dissolution shift
      upon accelerated stability by multivariate methods
    - A Lifecycle Concept for Pharmaceutical Analysis (link)
    - Quality by Design for Analytical Methods: Implications for
      Method Validation and Transfer (link)
    - Analytical Quality by Design (AQbD) in Pharmaceutical Development (link)
    - Analytical Quality by Design in the Pharmaceutical Industry (link)
    - USP PF, Stimuli Article, Lifecycle Management of Analytical Procedures:
      Method Development, Procedure Performance Qualification,
      and Procedure Performance Verification (link)
  • FDA Presentation:
    - QbD Considerations for Analytical Methods - FDA Perspective
    - Quality by Design Approaches to Analytical Methods - FDA Perspective
      (2011)
  • ICH Guidelines for the Industry
    -
    Validation of Analytical Procedures: Text and methodology (ICH Q2)
  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar

Six step process for method development and validation by QbD

QbD starts with defining the Analytical Target Profile 
The seminar explains all six steps using examples. 

Who should attend?

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Validation specialists

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT and many other  conferences and has been awarded as IVT's  'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,