FDA Announces NIPP For Sterile Injectable Drugs

FDA QSR cGMP Training Courses by SkillsPlus International Inc. “This New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings. The protocols also include additional questions related to quality culture observed in facilities. […]

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FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

“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 […]

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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 […]

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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 […]

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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 […]

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