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 349

FDA Compliant HPLC 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

Testimonials

We have received very positive feedback from attendees of previous seminars. To learn how the seminar helped to qualify and test HPLC systems, click here

Introduction

High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis. The main challenge is to do the right testing in the right sequence.

Key Questions related to HPLC Qualification and Performance Testing are:

• What does FDA say about HPLC calibration, qualification and testing?
• What exactly are the expectations of inspectors?
• What is the difference between calibration, qualification and testing?
• Why should we qualify HPLC 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 HPLCs, the vendor, user, 3rd party?
• Do we also need to qualify HPLC 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 HPLCs 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
• HPLC qualification according to USP <1058>
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Selecting parameters and acceptance limits for HPLC 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

• Example SOPs:
  - Qualification of High Performance Liquid Chromatographs
  - Testing of High Performance Liquid Chromatographs
  - Change control for analytical equipment
  - Development and Maintenance of Test Scripts for Analytical Systems
•  Eight templates/examples - HPLC System
  - HPLC System - Validation plan
  - HPLC System - Requirement Specifications
  - HPLC System - Vendor assessment
  - HPLC System - Design Qualification
  - HPLC System - Installation Qualification
  - HPLC System - Operational Qualification
  - HPLC System - Performance Qualification
  - HPLC System - Test Sheet
  - HPLC System - Summary report
• Equipment Validation Master Plan
• Reference Articles
  - Selecting Parameters and Limits for Equipment Operational Qualification
  - Operational Qualification in Practice
• Warning letters and Inspectional observations related to HPLC testing.
• FDA Publication: Overview of Equipment Qualification, Including HPLC Testing
• Seven Examples for FDA Warning Letters Related to HPLC Testing

OQ Testing - HPLC Fluorescence Detector 

 All HPLC modules should be tested as part of the system. Here is an example for the fluorescence detector. Attend the seminar to learn about test parameters of other modules.

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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

 

• Dr. Beatrisa Aronchik, Affymax, QC manager, USA
  The seminar did exceed my expectations
  The presented slides outlined all aspects of the current requirements to the HPLC qualification. The presenter demonstrated great knowledge in the topic during the presentation and Q&A session.  As a QC lab manager I have a lot of experience with the HPLC system qualification and was happy to see that we follow the recommendations. Thank you for a great audio seminar. I really appreciate your website that has many useful links. (Ref 1037)
  
• Mr Daniel Hollingshead, AMT Labs, Inc., Lab Supervisor. Analytical Lab
  The seminar provided clear and concise information. Templates will make it very easy to implement qualification and performance testing program. You have a very impressive list of topics.I look forward to purchasing additional seminars in the near future. (Ref 1101)

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.

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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

	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,