Quality Control Laboratory Compliance Seminar: cGMPs and GLPs - San Francisco, CA, United States - March 29th-30th, 2018

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).

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).

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.

Learning Objectives:

Who Should Attend:

Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.

Agenda:

Day 01 (8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Basics of FDA law and regulations for QC laboratories

Laboratory Organization

Documentation and record-keeping requirements

Sample integrity requirements

Stability (shelf-life) studies

Day 02 (8:30 AM - 1:00 PM)

Analytical methods verification and validation

Management and control of laboratory instruments

Management and control of laboratory supplies

Proper conduct of laboratory investigations

Consequences of laboratory non-compliance

For more information about this conference visit https://www.researchandmarkets.com/research/cpqtf9/one_and_a_half?w=5

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com  

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