One and a Half-day Quality Control Laboratory Compliance Seminar: cGMPs and GLPs (San Francisco, CA, United States – November 9-10, 2017) – Research and Markets

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Quality
Control Laboratory Compliance – cGMPs and GLPs: One and a Half-day
In-person Seminar” conference to their offering.

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).

Learning Objectives:

– The basics of FDA law and regulations governing QC laboratories
responsible for testing research materials, components of FDA-regulated
products, and finished FDA-regulated products (pharmaceuticals,
biologics, medical devices, cosmetics, and foods).

– Laboratory organization, personnel qualification and training
requirements.

– Documentation and record-keeping requirements, including e-records and
data integrity.

– Sample integrity requirements.

– Management and control of stability (shelf-life) studies.

– 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 http://www.researchandmarkets.com/research/h9fgzv/quality_control

Contacts

Research and Markets
Laura Wood, Senior Manager
[email protected]
For
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Related
Topics: Pharmaceutical
Manufacturing