Good Manufacturing Practice Training
This training will review the current Good Manufacturing Practice (cGMP) regulations as defined by 21 CFR Parts 11, 210 and 211. Attendees will learn how to comply with these FDA regulations and avoid potential pitfalls.
Training materials include an audio-visual presentation with a competency assessment to confirm learning of key points. A printable course certificate is available upon completion of the course. Registration gives you immediate access to all online course materials for 30 days.
Key Topics
Overview of GMP requirements
History of cGMP
Establishing a Quality Culture
Electronic Records; Electronic Signatures
Data Integrity and cGMP
Quality Systems
Organization and Personnel
Buildings and Facilities
Equipment
Control of Components, Containers and Closures
Production and Process Controls
Packaging and Labeling
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged Drug Products
Inspection Trends
Who will benefit from this course
Senior Management
Manufacturing
CMC
Regulatory Affairs
Quality Assurance
Course Contents
One hour audio-visual presentation followed by a self-paced competency assessment. Course completion survey and printable training certificate.
Instructor
Brett Vengroff
About Online Training
ComplianceLogix provides GCP training, GLP training and cGMP training, Six Sigma training and related compliance training courses. Enjoy the benefits of a secure, real-time multimedia learning experience with no travel required. The resources you need are already at your fingertips - all you need is an internet connection. Learn information critical to your business needs, when you need it.