RAPS: This course has been pre-approved by RAPS as eligible for up to 10.0 credits towards a participant's RAC recertification upon full completion.
Maintaining compliance in a Quality Control (QC) laboratory is essential to ensuring product safety, data integrity, and regulatory approval. This course provides a comprehensive understanding of Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs), helping you navigate complex regulations and avoid costly compliance failures.
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).
Maintaining compliance in a Quality Control (QC) laboratory is essential to ensuring product safety, data integrity, and regulatory approval. This course provides a comprehensive understanding of Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs), helping you navigate complex regulations and avoid costly compliance failures.
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).
Course Content
DAY 01- Basics of FDA law and regulations for QC laboratories
- What is adulteration?
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is CGMP?
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is GLP?
- What is AIP?
- 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
- Stability (shelf-life) studies
- Organization and management
- Storage units
- Analytical methodology
- Analytical methods verification and validation
- Protocols
- Tests
- Documentation
- 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
Course Provider
Kelly Thomas,
Who Should Attend
- Quality Control (QC) & Quality Assurance (QA) professionals
- Laboratory managers & scientists
- Regulatory affairs specialists
- GMP & GLP auditors
- R&D and analytical chemists
- Anyone involved in compliance within a GMP-regulated laboratory
