This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include: annual product reviews, complaint files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification. Additional topics covered include how the International Conference on Harmonization (ICH) documents Q8, Q9 and Q10 relate to and support the quality system. This course is designed to provide broad, fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.
The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed.
Duration: 60 minutes Please note: You will have access to complete this course for 5 days after purchase.