Quality Control Laboratory Compliance - cGMPs and GLPs Course (2-Day Online Event, November 7-8, 2024)
Dublin, July 03, 2024 (GLOBE NEWSWIRE) -- The "Quality Control Laboratory Compliance - cGMPs and GLPs Course" training has been added to ResearchAndMarkets.com's offering.
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.
AGENDA
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
For more information about this training visit https://www.researchandmarkets.com/r/u9v8tp
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900