Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel

Website https://www.globalcompliancepanel.com/control/w_product/~product_id=600438?channel=mailer&camp=webin | Edit Freely

Category Health Care, Medical Device, Compliance Training

Deadline: April 19, 2011 | Date: April 19, 2011

Venue/Country: Wilmington, U.S.A

Updated: 2011-03-29 15:36:01 (GMT+9)

Call For Papers - CFP

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

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00