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
o User Requirement Specifications (URS) for analytical equipment
o Change control for analytical equipment
o Qualification of equipment
o 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
* 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:
* QA managers and personnel
* Analysts and lab managers
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultans
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
o User Requirement Specifications (URS) for analytical equipment
o Change control for analytical equipment
o Qualification of equipment
o 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
* 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:
* QA managers and personnel
* Analysts and lab managers
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultans
