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Quality Control Laboratory Compliance - cGMPs and GLPs

ComplianceOnline

Thursday, May 18, 2017 at 8:30 AM - Friday, May 19, 2017 at 1:00 PM (EDT)

Quality Control Laboratory Compliance - cGMPs and GLPs

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration May 18, 2017 $1,999.00 $0.00

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Event Details

Course Description:

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

 

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

 

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

Have questions about Quality Control Laboratory Compliance - cGMPs and GLPs? Contact ComplianceOnline

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When & Where


Philadelphia

Philadelphia, PA

Thursday, May 18, 2017 at 8:30 AM - Friday, May 19, 2017 at 1:00 PM (EDT)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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Quality Control Laboratory Compliance - cGMPs and GLPs
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