Job Description

📢 New Chapter Announcement
Online CMC Regulatory Affairs Training
Biologics, Biosimilars & Vaccines

CMC Strategies for Drug Product Formulation Development & CMC Data Generation
Fortunate-Veda RA Trainings is pleased to announce a new chapter of our 3-Month Online CMC Regulatory Affairs Course, starting 02 February 2026, delivered through Live Zoom Sessions.
🧪 Topics Covered
🔹 Insulin & analogs – formulation CMC strategies
🔹 Formulation excipients characterization
🔹 Sterile filtration & filter validation
🔹 Regulatory expectations for monoclonal antibody formulation
🔹 GMP formulation process flow
🔹 Aseptic media fill validation
🔹 Regulatory expectations for vaccine fill–finish processes
🔹 Process Validation (PV), Cleaning Validation (CV), Hold Time Studies (HTS)
🔹 Process Characterization (PC) & Cold Chain Validation
🔹 Statistical tools used in the biopharmaceutical industry
🔹 CPV & APQR trending strategies
🔹 DoE & JMP software applications
🔹 Regulatory expectations for Container Closure Systems (CCS)
🔹 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
✔ Gain end-to-end understanding of formulation and analytical CMC strategies
✔ Learn global regulatory expectations aligned with FDA, EMA, WHO & ICH
✔ Practical, submission-oriented insights for biologics, biosimilars & vaccines
📍 Program Details
📌 Mode: Zoom – Online Live Sessions
📅 Start Date: 02 February 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