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
10.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.
Course Content
DAY 01 (12:00 PM - 05:00 PM EST)
- 12.00 PM: 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
- Stability program
- Raw material reduced testing program
- Retention sample program
DAY 02 (12:00 PM - 05:00 PM EST)
- Analytical Method Validation and Transfer
- Data Integrity Program
- OOS Investigations
- Customer Compliant Investigations / Adverse Events
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. 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.
Who Should Attend
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
- Many more...
