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    Quality Control Laboratory Compliance - cGMPs and GLPs

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    Website http://bit.ly/29Ap7sf | Want to Edit it Edit Freely

    Category Laboratory Compliance;

    Deadline: November 03, 2016 | Date: November 03, 2016-November 04, 2016

    Venue/Country: Boston, U.S.A

    Updated: 2016-10-07 19:10:03 (GMT+9)

    Call For Papers - CFP

    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:

    Key goals of the conference will include learning:

    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.

    Who will Benefit:

    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.

    Quality Assurance

    Quality Control

    Research & Development

    Note:

    Use coupon code NB5SQH8N and get 10% off on registration.

    For Registration:

    http://www.complianceonline.com/quality-control-laboratory-compliance-cgmps-and-glps-seminar-training-80085SEM-prdsm?channel=ourglocal


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.