"Analytical methods verification and validation."
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency's evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).
- Laboratory organization, personnel qualification and training requirements.
- Documentation and record-keeping requirements, including e-records and data integrity.
- Management and control of stability (shelf-life) studies,Sample integrity requirements.
- Analytical methods verification and validation,Management and control of laboratory instruments.
- Management and control of laboratory supplies,Consequences of laboratory non-compliance.
Timings8:30 AM - 4:30 PM (Nov 18) (General)
8:30 AM - 1:00 PM (Nov 19) (General)
Entry FeesPaid Ticket Starts from 1699 USD View Details
5 Exhibitors Estimated Count
Category & TypeConference
Medical & Pharma
Editions18 - 19 Nov 2019 Interested
09 - 10 Nov 2017 3rd Edition
09 - 10 Nov 2017 2nd EditionView More
04 - 05 Aug 2016 1st Edition
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|1699 USD||Attendee Seminar One Registration|