“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act). The SSM will use risk factors consistent with section […]
Tag: cGMP
GMP Trainer Awareness, Certification, and Master Trainer Courses
GMP Trainer Awareness, Certification, and Master Trainer Courses Fees: Call us for individual or group pricing Questions? Call us: (415) 948-5220 This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training […]
Cut Training Costs With Online Learning – eLearning Industry
“However … Just like classroom training, online learning requires engagement at every level of the process. From upper management down to the learners themselves—there has to be some kind of engagement strategy in place. Without this high level of engagement, your training programme is doomed to failure. This means that your training’s return on investment is […]
Root Cause Analysis and Investigation Report Writing – New! – Online Self-Study Course
You asked for it, so we delivered! Learn more – Root Cause Analysis and Investigation Report Writing – Online Self-Study Course The most popular class with Allan Dewes, “Root Cause Analysis and Investigation Report Writing” is now available as an online self-study course. In 3-1/2 hours you’ll learn about the tools used to conduct a thorough […]
Free cGMP Tip on Root Cause Analysis (RCA)
Updated April 26, 2018 You asked for it, so we delivered! The most popular class with Allan Dewes, “Root Cause Analysis and Investigation Report Writing” is now available as an online self-study course. In 3-1/2 hours you’ll learn about the tools used to conduct a thorough deviation investigation. You’ll also learn great tips and get […]