A detailed understanding of calibration and qualification of lab equipments, development of qualification master plan, allocation of equipments to qualification categories A, B, C, the approach for existing system qualification.
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 know What FDA and other regulations say about equipment calibration and qualification? , the differences between calibration and qualification. How to develop and equipment qualification master plan, how does USP chapter <1058> fit in to calibration, what to do in qualification phases DQ, IQ, OQ, PQ. Also our expert Dr. Ludwig Huber will explain how to qualify/calibrate existing equipments.
Hand-Outs:
For easy implementation, attendees will receive
- 4 SOPs
- 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
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.
Who Will Benefit:
- By Laboratory/Industry
- Pharmaceutical development and quality control laboratories
- Food, environmental, clinical and chemical testing laboratories
- Suppliers of reference material
- Contract laboratories
- By function
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
- Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.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
