Compliance Trainings, Online
2015-08-24
Description : 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 2 SOPs Change control for analytical equipment Allocating Analytical Instruments to USP <1058> Categories 20+ Examples for Instrument OQ Testing Areas Covered in the Session : 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 Update on the new revision of USP <1058> Who Will Benefit: A must attend webinar for professionals in Small, midsize and large Pharmaceutical companies, API manufacturers, Clinical testing laboratories and Contract manufacturers and laboratories. Those who will benefit the are: QA Managers and Personnel Analysts and Lab Managers QA Managers and Personnel Regulatory Affairs Training Departments Documentation Departments Consultants
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