Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel 2011
19 Apr 2011
Webinar
Overview: 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.
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
Allocating Analytical Instruments to USP <1058> Categories
Areas Covered in the Session:
Operational lab equipment requirements for calibration and 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:
QA managers and personnel
Analysts and lab managers
Analysts
QA managers and personnel
Regulatory affairs
Training departments
Documentation department
Consultans
Past Events
Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel 2011 - 19 Apr 2011, Webinar (14922)
Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel 2026
Important
Please, check "Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Hospitals & Clinics, Medical device, Medical laboratories
