Cleaning Validation Masterclass: Why 10ppm is Dead (PDE & HBEL Explained) скачать в хорошем качестве

Cleaning Validation Masterclass: Why 10ppm is Dead (PDE & HBEL Explained)

Still using the 1/1000th dose or 10ppm rule for cleaning validation? You might be falling behind regulatory expectations. ​In today’s video, we’re unpacking the fundamental shift from arbitrary limits to science-based toxicology. Whether you're prepping for an FDA audit or optimizing your GMP facility, understanding PDE (Permitted Daily Exposure) and HBEL (Health-Based Exposure Limits) is no longer optional—it’s the gold standard. ​What You’ll Learn: ​Why the industry moved away from the 10ppm rule. ​How to decode an HBEL report. ​The step-by-step MACO calculation formula. ​The evolving role of the Toxicologist in QA. ​📌 Timestamps: 0:00 The Evolution of Cleaning Validation 0:50 Why 10ppm Isn't Scientific Enough 1:10 Decoding the HBEL Report 1:27 What is PDE? (The Golden Number) 1:49 How a PDE is Born: Safety Factors & NOAEL 2:32 The Toxicologist: Your New QA Partner 3:10 Calculating Your Limit: From PDE to MACO 4:34 The MACO Formula Explained 5:24 Why HBEL Matters for Patient Safety 6:05 Championing Patient Safety in Your Org ​ ​#PharmaceuticalManufacturing #CleaningValidation #QualityAssurance #GMPCompliance #FDA #MHRA #PharmaQA #Toxicology #PatientSafety #MACO #HBEL #TheIndianPharmacist #usfda