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Navigating the U.S. regulatory landscape for the use of high‑purity alcohols in biologic development and manufacturing processes is crucial for maintaining product quality and patient safety—from identifying a source manufacturer to transport logistics and storage.
Biomanufacturers face significant challenges due to supply chain uncertainty, potential physical harm associated with alcohol handling, and misunderstanding of regulatory guidelines, all of which have the potential to result in financial losses.
In this webinar regulatory, quality, and supply chain experts provide guidance and best practices regarding the purchase, handling, and applications of high‑purity alcohols in biopharma processes.
Learning objectives:
- Understand the critical compliance requirements and safety protocols for industrial alcohols
- Review the governing bodies involved in high-purty alcohol management
- Explore tips for sourcing, purchasing, transporting, and storing
- What to look for in manufacturing and supply partners for industrial alcohols
Speakers:
Amanda Kelty
Director of Regulatory Compliance,
Greenfield Global
Amanda has 10+ years of experience in the distilled spirits industry. She is focused on compliance for alcohol, food, safety, and environmental regulations of local, state, and federal agencies for Greenfield Global's specialty chemicals business. Amanda has built a TTB compliant records system, resulting in a TTB audit with zero violations.
Jai Murthy, PhD
Director of Product Management for CGMP Chemical Sourcing,
Thermo Fisher Scientific
Jai Murthy has a PhD in molecular biology and 20+ years of experience in the life science industry. His areas of expertise are in bioprocessing workflows, molecular diagnostics, and life sciences tools. Jai is passionate about helping biopharma companies streamline and scale pre‑production processes, so they can accelerate critical milestones.
Todd Newsome
Senior Manager for Regulatory Compliance and EH&S,
Thermo Fisher Scientific
Todd Newsome has 20+ years of experience in the life science and distribution industries. His areas of expertise are in operational regulatory compliance, risk management, health, safety, and security. Todd is focused on reducing storage, distributing hazardous products risks, and maintaining permit requirements to ensure uninterrupted supply.
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