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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 282

FDA Compliant SFC Qualification and Performance Testing

Learn how to select, conduct and document the right tests in the right sequence

Recorded, available with all reference material at any time

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The Application of Supercritical Fluid Chromatography (SFC) in Pharmaceutical and Biopharmaceutical industry is rapidly expanding from  research to development and to quality control in manufacturing. The reason is that new instruments have been developed that provide the performance, reliability and robustness that are required by various regulations and guidelines. This means that now SFC equipment should be qualified. Because there is no or little experience with SFC qualification the industry has many questions.

Key Questions related to SFC Qualification and Performance Testing are:

  • What does FDA say about SFC calibration, qualification and testing?
  • What exactly are the expectations of inspectors?
  • What is the difference between calibration, qualification and testing?
  • Why should we qualify SFC equipment if we perform system suitability testing every day?
  • Which parameters should be tested and what are the acceptance criteria?
  • Should we test parameters over the entire range, or is it enough to test at one point?
  • How to optimize all the tests and sequence for highest efficiency and compliance?
  • When and how much should we re-qualify, e.g., after repair, or after instrument move? 
  • Who can or should test SFCs, the vendor, user, 3rd party?
  • Do we also need to qualify SFC used in R&D?
  • What to test after changes, e.g., when the equipment is moved, repaired or updated?
  • We want to use our non-qualified SFCs for regulated work, what should we do?

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:

  • FDA and equivalent international requirements
  • Examples for recent 483s and Warning Letters for equipment qualification
  • SFC instrument qualification according to USP <1058>
  • Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Selecting parameters and acceptance limits for SFC initial and on-going testing
  • Recommended test sequence for highest efficiency
  • Approach for existing systems
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Documentation requirements

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

  • Slides as PowerPoint Presentation
  • Script
  • Q&As from before, during and after the seminar
  • Example SOPs:
    - Qualification and Calibration of SFC Systems
    - Performance Testing of SFC Systems
    - Change control for equipment
    - Maintenance of equipment
  •  Eight templates/examples - SFC Equipment Qualification
    - Qualification plan
    - Requirement Specifications
    -
    Vendor assessment
    - Design Qualification
    - Installation Qualification
    - Operational Qualification
    - Performance Qualification
    - Summary report
  • Equipment Validation Master Plan
  • Examples for FDA Warning Letters Related to Laboratory Equipment Qualification.
  • FDA presentation: Overview of Equipment Qualification,

Who should attend?

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

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 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.

vDr. 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 explined FDA'snext 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,