2015 - Webinar On Calibration and Qualification in Analytical Laboratories

Description :
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
2 SOPs
Change control for analytical equipment
Allocating Analytical Instruments to USP <1058> Categories
20+ Examples for Instrument OQ Testing
Areas Covered in the Session :
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
Update on the new revision of USP <1058>
Who Will Benefit:
A must attend webinar for professionals in Small, midsize and large Pharmaceutical companies, API manufacturers, Clinical testing laboratories and Contract manufacturers and laboratories. Those who will benefit the are:
QA Managers and Personnel
Analysts and Lab Managers
QA Managers and Personnel
Regulatory Affairs
Training Departments
Documentation Departments
Consultants