Job Description

Dear Professionals,
Fortunate-Veda Biologics Trainings is pleased to announce a Certified Training Program on:
Vaccines, Biologics & Biosimilars – Regulatory Affairs & GMP Expectations
High-Level CMC Strategy Principles and Submission-Package Checklist
(GMP / cGMP Perspective)
📅 Start Date: 12th January 2026 onwards
🕘 Time: 8:30 PM – 10:00 PM (IST)
💻 Mode: Live Interactive Zoom Sessions

🔬 Key Training Topics – Overview
1️⃣ Equipment / Instrument Qualification
Case Study: AHU Systems
• Qualification principles and documentation flow
• URS–DQ–IQ–OQ–PQ lifecycle approach
• HVAC and AHU qualification – key parameters and acceptance criteria
2️⃣ Cleaning Validation & Regulatory Strategy
• Designing cleaning validation studies
• MACO determination and worst-case product selection
• Regulatory expectations (USFDA, EMA, WHO)
3️⃣ Process Validation & Regulatory Strategy
• Process validation lifecycle – Stage 1, 2, and 3
• PPQ approach and continued process verification
• Global regulatory submission considerations
4️⃣ Submission Package Preparation
• CMC structure and submission checklist
• Regional expectations: US, EU, WHO
• Documentation practices and regulatory communication
5️⃣ ALCOA & Data Integrity Principles
• ALCOA+ framework and practical implementation
• Common data integrity observations and CAPA examples
6️⃣ Cleanroom Area Classification
• EU-GMP vs ISO 14644 requirements
• Cleanroom qualification and environmental monitoring strategy
7️⃣ Stability Studies at Different Stages
• Development, registration, and commercial stability programs
• Bracketing, matrixing, and accelerated studies
• Stability trending and data evaluation for submissions
8️⃣ Understanding GxP Systems
• Non-GMP, GLP, GDP, GMP & cGMP – overview and applicability
• Interrelationship between quality systems and compliance programs


🎓 Who Should Attend
Pharma, Biopharma, Vaccines, Biosimilars, Quality, Manufacturing, CMC, and Regulatory Affairs professionals.
📜 Certification:
Participants will receive a Certificate of Completion from Fortunate-Veda Biologics Trainings.


📞 For enrollment and details:
🌐 Website: www.fortunateveda.com
📧 Email: fortuneveda@gmail.com
📱 WhatsApp/Call: +91-8603223334
Warm regards,
Fortunate-Veda Biologics Trainings
Empowering Regulatory & GMP Excellence