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

Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
Part II: Changing Separation Conditions (link)

2. Analytical method validation - A Regulatory Perspective

System Suitability in HPLC Compendial Methods (H. Pappa)

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
To share this seminar info with your colleagues, click here

On-line Audio Seminar 251

System Suitability Testing for FDA and USP Compliance

With 10+ Best Practices for easy Implementation

Recorded

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System suitability testing (SST) is required in by USP and FDA to check and ensure on-going performance of a analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation.  Also, the USP chapter <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. So there are many questions.      

Key questions related to system suitability testing are:

  • What are FDA requirements for SST?
  • What are the most frequently found deviations?
  • What are compendial requirements for SST?
  • What are the changes with the updated chapter <621>
  • What is the significant differences between USP and EP?
  • What should be tested and when?
  • USP specified tests and criteria for chromatographic methods, but what about non-chromatographic methods?
  • When can SST substitute performance qualification (PQ)?
  • When should SST be conducted: before, in between or the end of a sequence?
  • We regularly run quality control samples, why do we need SST?
  • What are realistic test parameters and limits?
  • How much can I change a compendial method without revalidation?
  • How much can we change a home made method without revalidation?
  • How should we 'formally' document system suitability testing

How does the this 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 and checklist will help immediate and cost effective implementation.

During the interactive presentation you learn about:

During the interactive presentation you learn about:

  • FDA and International requirements for system suitability testing
  • Examples of FDA warning letters and how to avoid them
  • The role of SST for analytical quality assurance
  • SST in comparison with equipment qualification and quality control sample analysis
  • Most critical parameters for SST in EP and USP
  • Contents of the updated USP chapter <621>
  • Recommendations for implementing the new <621>
  • Developing an SOP for system testing testing
  • Criteria for SST timing within a sequence of sample runs
  • The role of SST for method changes according to the new chapter <621>.
  • Criteria for revalidation for method changes
  • Case studies with practical advice for test parameters and limits
  • Documenting SST test runs

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

  • SOPS: 
    - System Suitability Testing in Chromatography
    - Change Versus Adjustment of Compendial Methods
  • Examples:
    - Protocols for Occasional  and Ongoing System Suitability Tests
    - Performance Qualification for HPLC
  • Templates/Checklist:
    - System Suitability Testing
    - Laboratory Audits
  • Reference article
    Adjusting Conditions for a Routine Reversed phase HPLC assay. Part II: Changing Separation Conditions
  • FDA Guidance: Analytical Procedures and Methods Validation
  • FDA and USP Presentations on method validation and System Suitability Testing
    - HPLC Equipment Qualification, Includes recommendations for acceptance criteria
    - System Suitability Testing in HPLC Compendial Methods, H. Pappa, USP
  • ICH Guidelines for the Industry
    - Text on Validation of Analytical Procedures
    - Validation of Analytical Procedures: Methodology
  • Five Warning letters and/or Inspectional observations related to system suitability testing

Who should attend?

  • (Bio)Pharmaceutical, Device and API Industry
  • 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,