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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
To share this seminar info with your colleagues, click here

On-line Audio Seminar 370

Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on conducting risk assessment

Recorded, available with all reference material at any time

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Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.  In addition FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory  resubmission and approval. And the new FDA Method Validation Guide suggests using QbD elements such as risk assessmentfor development and validation. Because there is no or little experience with the QbD approach for analytical methods the industry has many questions.

Key Questions related to Quality by Design and Method Validation

  • What does it mean: Quality by design?
  • What is the regulatory background: ICH, FDA, USP, Europe, Asia, PIC/S?
  • Where and how is the industry already using the QbD approach?
  • Why should we change the way we develop and validate methods?
  • What is the main difference to the current validation approach based on ICH Q2?
  • What are the advantages of QbD for method validation and routine use?
  • ow to manage and conduct the risk assessment process
  • What are the drawbacks, if there are any?
  • What are the most cost-effective steps of the QbD approach?
  • How to define the 'design space'?

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.

During the interactive presentation you learn about:

  • General principles and key benefits of QbD
  • Regulatory background and trends: FDA, ICH Q8/9/10
  • Reasons for changing the way we validate methods
  • Current applications of QbD in the pharmaceutical industry
  • The Application of QbD for analytical methods
  • Comparison of the QbD process with ICH Q2 and USP <1225>
  • Benefits for method transfer and routine use
  • Using the lifecycle approach for method design, development and validation
  • Developing specifications and, the analytical target profile
  • Documenting input variables for risk assessment in fishbone diagrams
  • Using the risk assessment prioritization matrix to select the test parameters
  • Traditional vs. the QbD process for method parameter optimization
  • The method validation and qualification studies
  • Using the method in the routine: on-going performance control, review and  and change control
  • Continuous monitoring and improvements
  • Documentation requirements
  • Defining the Analytical Target Profile (ATP) and design space
  • Case studies

 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
  • SOPs
    - Development and Validation of
    Analytical Methods through Quality by Design
    - Transfer of Analytical Methods
  • Checklist :
    - Validation of Analytical Methods according  to the FDA Guidance 201
    Transfer of Analytical Methods and Procedures
  • Templates
    - Analytical Target Profile for selected HPLC methods
    - Design space for selected HPLC methods
    - Risk Prioritization Matrix for Quality by Design based Method Validation
  • Reference Articles
    QbD for Better Method Validation and Transfer (link)
    - Quality by Design Systematic Chromatographic Method Development
      (Poster, link)
    - 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)
  • An Example for Immediate-Release Dosage Forms Using QbD
  • FDA Presentation:
    - Regulatory considerations of the QbD approach for analytical methods
    - FDA Update on Implementation of Quality by Design (QbD)
  • FDA Warning-letters related to method validation
  • ICH Guidelines for the Industry
    Validation of Analytical Procedures: Text and methodology
    - ICH Q8, Q9, Q10
  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar

QbD steps for analytical methods

Attend the seminar to get detailed information on all six QbD steps for method design, development, validation, on-going control and continuous improvement. Specifically we will discuss the risk assessment process.


Risk assessment is a key element of QbD. Subject Matter Experts (SMEs)agree in a meeting on the impact of method variables on method attributes. Operational limits of method variables will be determined in Design of Experiment (DoE) Studies. Attend the seminar to learn how.

Who should attend?

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

Date and time

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 conferences and has been awarded as the '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,