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