Certified Training Program on: Vaccines, Biologics & Biosimilars – Regulatory Affairs & GMP Expectations

Course, Events
Online/Remote
April 12, 2026
Temporary

Job Overview

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 & Submission Package Checklist
(GMP / cGMP Perspective)
πŸ“… Start Date: 13th April 2026 onwards
πŸ•˜ Time: 8:30 PM – 10:00 PM (IST)
πŸ’» Mode: Live Interactive Zoom Sessions

Register


Key Training Topics – Overview
πŸ”Ή hashtag#Equipment/Instrument Qualification & Technology Transfer
β€’ AHU systems qualification: principles and documentation flow
β€’ URS–DQ–IQ–OQ–PQ lifecycle approach
β€’ HVAC/AHU qualification: key parameters & acceptance criteria
πŸ”Ή hashtag#CleaningValidation & Regulatory Strategy
β€’ Study design, MACO calculation, worst-case selection
β€’ Regulatory expectations (USFDA, EMA, WHO)
πŸ”Ή hashtag#ProcessValidation & hashtag#Regulatory Strategy
β€’ hashtag#Lifecycle approach: Stage 1, 2 & 3
β€’ hashtag#PPQ and continued process verification
β€’ Global regulatory considerations
πŸ”Ή Submission Package Preparation
β€’ hashtag#CMC structure & submission checklist
β€’ Regional expectations: US, EU & WHO
β€’ hashtag#Documentation practices & regulatory communication
πŸ”Ή hashtag#ALCOA+ & Data Integrity Principles
β€’ Practical implementation
β€’ Common observations & CAPA examples
πŸ”Ή Cleanroom Area Classification
β€’ hashtag#EU-GMP vs ISO 14644 requirements
β€’ Qualification & environmental monitoring strategy
πŸ”Ή Technology Transfer in Biologics
β€’ Industry best practices
πŸ”Ή Understanding GxP Systems
β€’ Overview of GLP, GDP, GMP & cGMP
β€’ Interrelationship of quality systems & compliance

Who Should Attend
Professionals from:
Pharma & Biopharma

Vaccines & Biosimilars

Quality Assurance & QualityControl

Manufacturing &ProcessDevelopment

CMC & Regulatory Affairs

Certification
Participants will receive a Certificate of Completion from
Fortunate-Veda Biologics Trainings

Enrollment & Contact
🌐 Website: www.fortunateveda.com
πŸ“§ Email: fortuneveda@gmail.com
πŸ“± WhatsApp/Call: +91 79842 75451
πŸ‘€ Contact: Shipra Trivedi, Training Coordinator


Warm Regards,
Fortunate-Veda Biologics Trainings
Empowering Regulatory & GMP Excellence

Certified Training Program on: Vaccines, Biologics & Biosimilars – Regulatory Affairs & GMP Expectations

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