Quality Control Laboratory Compliance - cGMPs
and GLPs - Quality Control Training Seminar
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).
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.
Quality Control Laboratory Compliance - cGMPs and GLPs Course Outline:
Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Basics of FDA law and regulations for QC laboratories
What is adulteration?
What is CGMP?
What is GLP?
What is AIP?
FDA inspection methodology
Personnel qualification and training
Documentation and record-keeping requirements
Standard Operating Procedures
Raw data (notebooks, print-outs)
Document management (change control, retention)
Part 11 (electronic records and signatures)
Sample integrity requirements
Sample delivery, handling, disposition
Stability (shelf-life) studies
Organization and management
Day Two (8:30 AM - 1:00 PM)
Analytical methods verification and validation
Management and control of laboratory instruments
Management and control of laboratory supplies
Proper conduct of laboratory investigations
Root cause analysis
Consequences of laboratory non-compliance