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Analytical method validation - A Regulatory Perspective

Verification of Compendial Procedures

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

 

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 254

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA compliance

Recorded, available at any time

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High-performance Liquid Chromatography (HPLC) is the most frequently used analytical technique in (Bio)pharmaceutical development and QC laboratories. Methods should be validated to ensure consistency and accuracy of analytical data to make reliable decisions about safety and quality of medicinal products. Method development and validation are not independent from each other. Methods should be designed and developed using the "Quality by Design" concept with robustness for routine use in mind. Validation experiments and documentation must meet ICH Q2(R1) requirements. Therefore without good guidance the process can be quite time consuming and include high compliance risks.  

Key Questions related to Analytical Method Validation are:

  • What are FDA and international requirements?
  • What exactly are the expectations of inspectors?
  • What does (Quality by Design) mean for method development and validation?
  • Which parameters should be validated?
  • What are the validation requirements for preclinical and clinical phases I,II, and III?
  • Is there an ideal sequence for conducting validation experiments?
  • Are there good recommendations for acceptance criteria?
  • Who should get involved in method validation: development/QC labs?
  • Should compendial HPLC methods be validated?
  • Should we re-write compendial methods or can we use them as our SOP?
  • What information must be included in regulatory submissions?
  • I want to transfer a method from development to routine lab, do we need to revalidate?
  • We want to transfer a method to an other site, do we need to revalidate?
  • When should methods be revalidated and formally reviewed?
  • We have changed our method, should we revalidate?
  • We use software for automated method validation, should it be Part 11 compliant?

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 give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international regulations and guidelines
  • Examples of warning letters and how to avoid them
  • Strategy for integrated method development and validation
  • Using the the Quality by Design (QbD) concept to ensure method robustness for routine use
  • Writing the validation plan
  • Selecting the right HPLC instrumentation: isocratic/gradient, PDA, LC/MS
  • Selecting parameters and conditions for HPLC method validation
  • Optimizing the sequence of experiments for HPLC method validation
  • Phase-appropriate method validation: preclinical, clinical I,II,III, manufacturing
  • Selecting acceptance criteria for HPLC method validation
  • Verification of compendial methods
  • Strategies for compliant method transfer
  • Regular revalidation and review of HPLC methods
  • Revalidation requirements after changes
  • Using software for automated method optimization and validation
  • Documentation for the FDA, other agencies

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

  • 67-page primer: Validation of Analytical Methods
  • Validation Plan: Template and Examples
    HPLC Method Validation
  • Validation Report; Template and Examples
    HPLC Method Validation
  • SOPs
    - Validation of HPLC Methods
    - Transfer of Analytical Methods
    - Verification of Compendial Methods
    - Change versus Adjustment of Compendial Methods
  • Checklist:
    - Validation of Analytical Methods
  • Reference Articles
    - Validation of Analytical Methods: Review and Strategy
    - Validation of HPLC methods
    - Evaluation and Validation of Standard Methods
  • Five Warning letters and/or Inspectional observations related to HPLC method validation
  • FDA Guidance and Policy: (draft)
    - Analytical Procedures and Methods Validation
  • FDA presentation on method validation
    - Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry
    - Text on Validation of Analytical Procedures
    - Validation of Analytical Procedures: Methodology

Who should attend?

  • (Bio)Pharmaceutical, Device and API Industry
  • Development groups
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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