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Quality Control Laboratory Compliance - cGMPs and GLPs

in IFSQN Events Calendar
Added by Harshit Choudhary, 17 Jul 2013

Taking place 17 Oct 2013 through 18 Oct 2013 (Ranged Event)

Harshit Choudhary

Logo URL
Event Organizer Compliance Online
Contact Name Harshit Choudhary
Contact Number +1-888-717-2436

Event Category Training Course
Event State/City Boston, MA
Event Country USA
Cost of Attendance $1,199.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/seminar?product_id=80085SEM&channel=am_IFSQN

Event Description

Thursday, October 17, 2013, 8:30 AM to 4:30 PM EDT and Friday, October 18, 2013, 8:30 AM to 1:00 PM EDT, Boston, MA

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
Meet Your Instructor:

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Martha Bennett
Principal, Bennett and Company (Ex-FDA Professional)

Martha M. Bennett, RAC, has more than 40 years of experience in the area of U.S. FDA law and regulations as an investigator, compliance officer, policy advisor to three commissioners, and consultant to companies worldwide regulated by the agency. Ms. Bennett provides a variety of regulatory affairs and quality system (GxP) consulting services to FDA regulated companies worldwide, covering foods, drugs and biologics, medical devices, and cosmetics. Based on almost forty years of experience within and outside of FDA, she assists companies with compliance, product development and approval, and post-marketing issues. Using risk management tools, (e.g., Six Sigma, FMEA, HACCP), she assists companies with validation strategy, planning and execution. She conducts FDA and quality focused audits and training. Thoroughly grounded and experienced in FDA law and regulations, she also provides consulting services to legal teams as well as expert testimony. She was an FDA field investigator, senior compliance officer, and policy analyst for three FDA Commissioners. She is a board member for ASQ-FDC (American Society for Quality – Food, Drug & Cosmetic Division) and SQA (Society of Quality Assurance – Education Committee). Based on her experience and contribution to the profession, she was named a RAPS Senior Fellow.

Further details and registration >>

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