Dublin, Feb. 09, 2024 (GLOBE NEWSWIRE) -- The "Quality Control Laboratory Compliance - cGMP and GLP Training" has been added to ResearchAndMarkets.com's offering.
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.
SEMINAR 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.
SEMINAR AGENDA
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
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
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
For more information about this training visit https://www.researchandmarkets.com/r/ka3ti7
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