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:
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.
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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
- 09.00 AM: Session Start
- 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
- What is adulteration?
- 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
Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer
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.
Testimonials
See What People Say About Us
Manager, Quality Control,
Quanterix Corporation
Quality Assurance Coordinator,
Procter & Gamble
Research & Development,
Estée Lauder Companies
Quality & Safety Compliance Manager,
Alaffia
Research & Development,
Estée Lauder Companies
Quality Control Supervisor,
International Flavors & Fragrances Inc.
Food Safety and Quality Coordinator,
The Raymond-Hadley Corporation
Quality Control Analyst,
Fagron
Manager Quality Engineering,
Nuskin Products, Inc
Sr. VP Operations,
Hologic Gen-Probe
Sr. Director QC,
Hologic Gen-Probe
Quality Control Manager,
ProZyme, Inc.
QA/QC Manager,
Nellson Nutraceutical
QA Manager,
Specialty Silicone Fabricators, Inc.
QC Lab Manager,
Usana Health Sciences
GxP Vendor Compliance Management,
AbbVie Laboratories
Lab Manager,
PaxVax, Inc.
Associate Professor,
University of Miami
Quality Control Manager,
Earthrise Nutritionals
Senior Scientist,
Clorox Services Company
Scientist I,
ViaCyte, Inc
Director of Regulatory Affairs,
Nickell Physician & Pharmacy Services
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