Recorded Webinar: FDA Compliant HPLC Qualification and Performance Testing

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ludwig Huber

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

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.

Areas Covered in the Session:
- FDA and equivalent international requirements
- Examples for recent 483s and Warning Letters
- HPLC qualification according to USP
- 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

Who Will Benefit:
- QA managers and personnel
- Analysts and lab managers
- Analysts
- Regulatory affairs
- Training departments
- Documentation department
- Consultants

Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

After your payment, we will contact you with instructions about how to access the webinar.
After your payment, we will contact you with instructions about how to access the webinar.
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