July 18 - 19, 2024 | US Eastern Time: 9 AM to 2 PM | Central Europe Time: 3 PM to 8 PM


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Ensuring compliance with FDA regulations is crucial for companies operating in industries such as pharmaceuticals, biologics, medical devices, foods, and cosmetics. The FDA conducts inspections and oversees quality control (QC) laboratories to evaluate compliance status, and non-compliance can result in serious consequences such as regulatory actions, hefty fines, and even criminal charges.

This course offers comprehensive training on the essential requirements for all QC laboratories subject to FDA inspection. Participants will learn about recent trends in FDA inspection reports and enforcement actions, as well as relevant regulations and guidelines. Quality control and quality assurance personnel will also learn how to monitor industry practices to stay up-to-date with FDA requirements, including cGMPs and GLPs. Enroll in this course to ensure your QC laboratory is compliant and avoid costly consequences.

  1. 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).
  2. Laboratory organization, personnel qualification and training requirements.
  3. Documentation and record-keeping requirements, including e-records and data integrity.
  4. Sample integrity requirements.
  5. Management and control of stability (shelf-life) studies.
  6. Analytical methods verification and validation.
  7. Management and control of laboratory instruments.
  8. Management and control of laboratory supplies.
  9. Proper conduct of laboratory investigations.
  10. Consequences of laboratory non-compliance.

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 Personnel
- Quality Control Personnel
- Research and Development Personnel
- Regulatory Affairs Personnel
- Project Managers
- Manufacturing Managers
- Validation Engineers
- Internal Auditing Personnel
- Microbiology Personnel
- Auditors


DAY 1 (9 AM to 2 PM)

Understanding FDA law and regulations for QC laboratories

What is adulteration?
- Pharmaceuticals
- Biologics
- Medical Devices

What is CGMP?
- Pharmaceuticals
- Biologics
- Medical Devices

What is GLP?
- Contract Laboratories
- FDA inspection methodology

Laboratory Organization
- Organization
- Personnel qualification and training


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

Sample integrity requirements
- Sample collection
- Sample delivery, handling, disposition
- Retain samples

DAY 2 (9 AM to 2 PM)

Documentation (contd.)

Stability (shelf-life) studies
- Organization and management
- Storage units
- Analytical methodology

Analytical methods verification and validation
- Protocols
- Tests
- Documentation

Management and Control

Management and control of laboratory instruments
- Qualification
- Calibration
- Maintenance

Management and control of laboratory supplies
- Standards
- Reagents, chemicals

Proper conduct of laboratory investigations
- Out-of-specification results
- Out-of-norm results
- Root cause analysis
- Documentation

Consequences of Laboratory non-compliance

Interactive Discussions and Q&A Session

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.