ICH Q7 Explained: Deviation vs Non-Conformance, Training, and API Changes скачать в хорошем качестве

ICH Q7 Explained: Deviation vs Non-Conformance, Training, and API Changes

“Are deviation and non-conformance the same in ICH Q7? ❌ What does ‘training should be periodically assessed’ really mean? 📚 Who is responsible for notifying the drug product manufacturer about API changes? 🔄 In this video, I break down three critical ICH Q7 questions that every pharma professional must know to stay audit-ready: 1️⃣ Deviation vs Non-Conformance — what’s the real difference? 2️⃣ Training Assessment — why regulators demand periodic checks. 3️⃣ API Change Notifications — who holds the responsibility in the supply chain. If you’re working in pharma QA, QC, production, regulatory, or audits — this clarity can save you from warning letters and audit failures. 👉 Watch till the end and comment your biggest takeaway. 📌 DM me the word ICHQ7 to if want to learn in depth. Dr. Rupali Paranjape Auditor, Trainer & Mentor for Pharma Companies & Professionals 📧 rupali@blueoceancompliance.in 🌐 www.drrupaliparanjape.com Blue Ocean of Compliance Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation ________________________________ Blue Ocean of Compliance Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation Are you struggling to solve the problems of non-compliances on your site? Even with putting your best technologies, Knowledge, and efforts do you feel clueless? If you want to protect your site from risks & huge losses due to non-compliances, If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no-observation in a cost-effective way, Then do not miss "Blue Ocean of Compliance" #1 Best Seller book on Amazon by Dr. Rupali Paranjape. Why you must read this 👉By reading & implementing this you will be able to avoid more than 492, 483s on your site. 👉You will be able to avoid many circumstances that lead to Warning letters. 👉You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways. 👉You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site. 👉You will know one new thought process “Blue Ocean of Compliance” 👉At the end of each Chapter Practical Assignments: Exercise is given for implementation. The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shop floor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more. You may buy this book from amazon in India & globally. To book your copy click the below link; For India; Blue Ocean of Compliance https://amzn.in/9CNUVoz Out of India, you may book your copy from amazon.com. Blue Ocean of Compliance https://a.co/d/fu1fhjs _____________________________________________ #cgmp #pharmaindustry #ceos #founders #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #ceoinsights #audits #auditor #compliancesolutions #sops #MPharm, #bpharmacy, #mpharmacy, #pharmajobs, #procedures #analytical #validation #laboratory #21cfrpart11 #dataintegrity #documentation #gdprcompliance