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
- 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
