By : Compliance Online
Date : 2012
Location : California / Palo Alto
This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.
Equipment calibration compliance training, equipment qualification training, FDA laboratory regulations, FDA laboratory guidelines, FDA regulations compliance training
Why Should You Attend:
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
Attend this Webinar to learn what FDA and other regulations say about equipment calibration and qualification, and the differences between calibration and qualification. We will discuss how to develop an equipment qualification master plan and learn how the USP chapter <1058> fits in to calibration. The presenter, Dr. Ludwig Huber, will also explain how to qualify/calibrate existing equipments.
For easy implementation, attendees will receive
- User Requirement Specifications (URS) for analytical equipment
- Change control for analytical equipment
- Qualification of equipment
- Allocating Analytical Instruments to USP <1058> Categories
- 20+ Examples for Instrument OQ Testing
Note: These complimentary hand-outs will be sent to customers on request. Please email firstname.lastname@example.org for these documents, stating your order number, and they will be emailed to you within 4 working days.
Who Will Benefit:
The following personnel from pharmaceutical development and quality control laboratories, food, environmental, clinical and chemical testing laboratories and contract laboratories will benefit:
- QA managers and personnel
- Analysts and lab managers
- Regulatory affairs
- Training departments
- Documentation department
Areas Covered in the Seminar:
- Operational lab equipment requirements for calibration and qualification.
- Most common inspection problems.
- USP Chapter <1058>: Analytical Instrument Qualification.
- Development of an effective equipment qualification master plan.
- Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
- Allocating equipment to qualification categories A, B and C.
- Qualification and documentation requirements for each category.
- Going through the category example list.
- Approach for existing systems.
- Approach for automated systems (incl. firmware/computer systems).
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
- Documentation requirements.
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor ofwww.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com.
Recorded webinar and reference materials will be available on your account after purchase.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria