Job Description

New Chapter Announcement-
Online CMC Regulatory Affairs Training
Biologics, Biosimilars & Vaccines- Formulations.
CMC Strategies for Drug Product Formulation Development & CMC Data Generation
Fortunate-Veda RA Trainings is pleased to announce the launch of a new chapter of our 3-Month Online CMC Regulatory Affairs Course, starting 04 May 2026, delivered through Live Zoom Sessions.

🧪 Key Topics Covered
🔹 Insulin & analogs – formulation CMC strategies
🔹 Formulation excipient characterization
🔹 Sterile filtration & filter validation
🔹 Regulatory expectations for hashtag#monoclonal antibody formulations
🔹 GMP-based formulation process flow
🔹 Aseptic media fill validation
🔹 Vaccine fill–finish regulatory expectations
🔹 Process Validation (PV), Cleaning Validation (CV) & Hold Time Studies (HTS)
🔹 Process Characterization (PC) & Cold Chain Validation
🔹 Statistical tools in the biopharmaceutical industry
🔹 Continued Process Verification (CPV) & APQR trending strategies
🔹 Design of Experiments (DoE) & JMP software applications
🔹 Container Closure Systems (CCS) – regulatory expectations
🔹 Extractables & Leachables (E&L) studies
🔹 Elemental impurities – ICH Q3D compliance
🔹Nitrosamine impurities & risk assessment strategies
🔹 Biosimilarity assessment & analytical comparability

(QTPP, CPP & CQA alignment)
🎯 Learning Outcomes
✔ End-to-end understanding of formulation and analytical CMC strategies
✔ In-depth knowledge of global regulatory expectations (FDA, EMA, WHO, ICH)
✔ Practical, submission-oriented insights for biologics, biosimilars & vaccines
📍 Program Details
📌 Mode: Online Live Sessions (Zoom)
📅 Start Date: 04 May 2026
🕘 Schedule: Monday to Friday | 8:30 PM – 10:00 PM (IST)
📞 Contact & Registration
🌐 Website: www.fortunateveda.com
✉️ Email: fortuneveda@gmail.com
📱 Mobile: +91-8603223334