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Faculty: Kelly Thomas

  • Date: 11/17/2020 12:00 PM - 11/17/2020 04:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


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.

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Validation Teams
  • Project Managers
  • Engineering Departments
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Laboratory Personnel


Seminar Agenda         

Lecture 1:
– Basics of FDA law and regulations for QC laboratories
– FDA inspection methodology
– Laboratory Organization

Lecture 2:
– Documentation and record-keeping requirements
– Standard Operating Procedures
– Part 11 (electronic records and signatures)
– Sample integrity requirements
– Stability (shelf-life) studies

Lecture 3:
– Analytical methods verification and validation
– Management and control of laboratory instruments
– Management and control of laboratory supplies

Lecture 4:
– Proper conduct of laboratory investigations
– Out-of-specification results
– Out-of-norm results
– Root cause analysis
– Documentation
– Consequences of laboratory non-compliance