This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.
This Online training will discuss all details and give strategies and case studies for easy implementation.
Complimentary Hand-Outs:
For easy implementation, attendees will receive:
Why Should You Attend:
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.This Online training will discuss all details and give strategies and case studies for easy implementation.
Complimentary Hand-Outs:
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
Areas Covered in the Webinar:
- 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
- Quality Unit manager and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
Course Provider
Dr. Ludwig Huber,
