Regulatory Expectations for Handling Potent & Toxic Drugs:
Schedule M Guidance for Containment and Isolation Systems
A practical, regulator-aligned webinar on containment, facility design, operator safety, and environmental controls for HPAPIs and toxic compounds.
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What You’ll Learn
- Regulatory intent behind revised Schedule M
- Facility, HVAC & pressure cascade design
- Environmental & cross-contamination safeguards
- Containment strategies for HPAPIs
- Operator safety & personnel protection
- Compliance documentation & risk management
Who Should Attend
QA Heads
QC Managers
Validation Teams
Engineering & Projects
Production & Sterile Operations
Regulatory Affairs
Plant Heads
Conducted by Leading Industry Expert
Mr. Varadharaj Vijayakumar
Experienced Pharma/BioPharma professional with a strong foundation in pharmaceutical technical operations, specializing in aseptic processing, sterility assurance, and lyophilization technologies with a focus on driving technical excellence, optimizing manufacturing workflows, and ensuring compliance with global regulatory standards.
Areas of expertise include VHP cycle development, isolator technology integration, process validation, failure investigations, troubleshooting, and continuous improvement. Extensive experience facing FDA, EMA, MHRA, WHO, ANVISA, INVIMA, CDSCO, and other global GMP inspections—leading teams through audits, developing robust CAPA strategies, and ensuring sustained compliance.
Read More
Worked with some of the industry’s most respected pharmaceutical and biopharmaceutical organizations, including Wuxi Biologics Germany GmbH, Franz Ziel GmbH (Germany), Pfizer (India), Dr. Reddy’s Laboratories Ltd., Emcure Pharmaceuticals (Oncology Division), Biocon Biologics (India) Ltd., and Caplin Steriles.
Webinar Details
Date
10 Jan 2026
Time
10:30 AM (CET)
3:00 PM (IST)
Platform
Duration
60 Minutes + Live Q&A
