The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the cGMP regulations pertain to the quality control laboratory and product testing.
As a minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation each two years as part of the statutory inspection obligation.
This course will provide an overview of the Regulatory requirements governing QC Labs to ensure compliance with cGMP and GCP expectations. Practical examples, case studies, and hands-on activities will be used to illustrate FDA QC laboratory hot-button issues and regulatory compliance as related to the cGMP-compliant QC laboratory.
Learning Objectives:
- Discuss cGMPs as defined in 21 CFR 211 for Quality Control units, and how they apply to QC regulatory requirements
- Discuss GCP Laboratory regulatory requirements.
- Know how to efficiently address deviations and OOS results
- Discuss equipment calibration, qualification, and methods validation
- Explain the importance of accurately maintaining appropriate documentation
- Know how to implement and manage an effective Data Integrity Program
Areas Covered:
- USP Interpretations
- Laboratory Walk-through Inspection Coverage
- General GMP Requirements and Laboratory Controls
- Samples, reagents and reference standards
- Instrument calibration, maintenance, qualification and logbooks
- Investigations and change control
- Personnel qualification and training
- Stability program
- Raw material reduced testing program
- Retention sample program
- Microbiology Laboratory Controls
- Media control and media growth promotion, sterility testing, methods validation
- Laboratory Procedures and Documentation
- SOPs, raw data, electronic records
- Analytical Method Validation
- Laboratory OOS: Investigations and Retesting
- Elements of a Robust Data Integrity Program
Who will Benefit:
This course is intended for the Quality Control, Quality Assurance and Compliance professionals who are directly involved with laboratory operations, or responsible for the compliance and auditing of laboratory systems and controls. The information in this course may be beneficial for Regulatory Affairs professionals who are responsible for FDA submissions.
- QC Technicians
- QC Specialist
- QC Supervisors / Managers
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
- Seminar objectives review, expectations and scope.
- Review Regulations governing QC lab
- QC lab layout
- Equipment Overview
- Qualification
- Calibration
- Maintenance
- Documentation requirements
- Personnel qualification and training
- 12:00-1:00 Lunch
- Stability program
- Raw material reduced testing program
- Retention sample program
- Analytical Method Validation and Transfer
- Data Integrity Program
- 12:00-1:00 Lunch
- OOS Investigations
- Customer Compliant Investigations / Adverse Events
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
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Alaffia
Research & Development,
Estée Lauder Companies
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International Flavors & Fragrances Inc.
Food Safety and Quality Coordinator,
The Raymond-Hadley Corporation
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Fagron
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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
