©bongkarn thanyakij via Canva.com
Webinar on Calibration and Qualification in Analytical Laboratories
This Webinar is over| Date | Jun 10, 2014 |
| Time | 12:00 PM EDT |
| Cost | $245.00 |
|
Online
|
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:
Areas Covered in the Session:
GlobalCompliancePanel
USA Phone:800-447-9407
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1rla55u
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
- 20+ Examples for Instrument OQ Testing
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
- QA Managers and Personnel
- Analysts and lab Managers
- Analysts
- QA Managers and Personnel
- Regulatory affairs
- Training Departments
- Documentation department
- Consultant
GlobalCompliancePanel
USA Phone:800-447-9407
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1rla55u
Create your own event
Turn your passion into a business.
Turn your passion into a business.