Job Description

New Chapter Announcement – Online CMC Regulatory Affairs Training
Biologics | Biosimilars | Vaccines
CMC Strategies for Analytical Data Generation
Fortunate-Veda RA Trainings is delighted to announce the launch of a new chapter in our Online CMC Regulatory Affairs Course, starting 27 April 2026, delivered through live Zoom sessions.
🧪 Key Topics Covered
🔹 AnalyticalMethodDevelopment (AMD)
🔹 AnalyticalMethodQualification & MethodTransfer
🔹 AnalyticalMethodValidation (AMV)
🔹ProteinCharacterizationStrategies
🔹 ReferenceStandards
🔹 BiosimilarityAssessment & AnalyticalComparability (QTPP / CPP / CQA alignment)
🔹 Bioassays & Immunoassays
🔹 ExtractablesAndLeachables (E&L) – ICH Q3E
🔹 NitrosamineRiskAssessment – Regulatory Expectations
🔹 ElementalImpurityRiskEvaluation – ICH Q3D
🔹Statistics tools usage in Biopharma Industry

🎯 What You Will Gain
Develop in-depth expertise in Analytical CMC regulatory strategies for biologics, biosimilars, and vaccines—aligned with global regulatory expectations (FDA, EMA, WHO, ICH).
📍 Program Details
🖥️ Mode: Zoom – Live Interactive Sessions
🗓️ Start Date: 27 April 2026
⏰ Schedule: Monday to Friday | 08:30 PM – 10:00 PM (IST)
📞 Contact & Registration
🌐 www.fortunateveda.com
✉️ fortuneveda@gmail.com
📱 +91-8603223334
🚀 Upgrade your Analytical CMC expertise and accelerate your regulatory career with Fortunate-Veda!