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.

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

DAY ONE & DAY TWO

I. Basics of FDA law and regulations for QC laboratories

What is adulteration?

1. Pharmaceuticals
2. Biologics
3. Medical Devices
4. Foods
5. Cosmetics

What is CGMP?

1. Pharmaceuticals
2. Biologics
3. Medical Devices
4. Foods
5. Cosmetics

What is GLP?
What is AIP?
Contract Laboratories
FDA inspection methodology

II. Laboratory Organization

A. Organization
B. Personnel qualification and training

III. Documentation and record-keeping requirements
A. Standard Operating Procedures
B. Analytical Methods
C. Raw data (notebooks, print-outs)
D. Document management (change control, retention)
E. Part 11 (electronic records and signatures)

IV. Sample integrity requirements
A. Sample collection
B. Sample delivery, handling, disposition
C. Retain samples

V. Stability (shelf-life) studies
A. Organization and management
B. Storage units
C. Analytical methodology

DAY THREE

VI. Analytical methods verification and validation

A. Protocols
B. Tests
C. Documentation

VII. Management and control of laboratory instruments
A. Qualification
B. Calibration
C. Maintenance

VIII. Management and control of laboratory supplies
A. Standards
B. Reagents, chemicals

IX. Proper conduct of laboratory investigations

A. Out-of-specification results
B. Out-of-norm results
C. Root cause analysis
D. Documentation

X. Consequences of laboratory non-compliance