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Today’s traditional film coating systems currently offer a time-consuming process with increased costs implications. These low solids film coatings require a long processing time that reduces throughput creating major manufacturing bottlenecks. Additionally, these extended coating cycles increase energy, labor and overhead costs while limiting flexibility, making it harder to respond to demand and maintain profitability. While there are solutions available for faster coating process, regulatory concerns around coating changes often delay adoption and limit these benefits. Clear guidance and strategic regulatory planning are essential to unlocking the benefits of high solids coatings. Switching to a high solids film coating, like aquarius™ genesis, better and faster film coating system, can dramatically improve throughput and reduce overall costs.
In this webinar, our experts will guide you through the regulatory pathways, practical strategies and case studies needed to confidently implement aquarius™ genesis film coating system. Learn how to accelerate production, maintain compliance and unlock the full potential of your coating operations, with topics focused on:
Register for the webinar replay today to learn how to increase your plant’s coating capacity through navigable regulatory pathway.
presenter information:
Abha Pant
Qu Consulting Managing Member
Abha is a pharmaceutical executive with more than 20 years’ experience in regulatory, R&D, quality, compliance and operations. She specializes in world-wide regulatory activities, submission strategies and liaison spanning the USFDA, EU, Japan, Brazil, CIS countries, ASEAN countries, GCC and several emerging markets for new and commercialized products. Abha works closely with companies on regulatory and quality due diligence and remediation.
Kayla Allen
Ashland regulatory affairs specialist
With more than 10 years of pharmaceutical and nutraceutical experience, Kayla supports Ashland as a North America specialist for regulatory affairs. As part of her role, she develops drug master files, creates and manages customer-facing regulatory documentation to enhance Ashland’s iSolve℠ on-demand customer portal, and provides intelligence on pressing regulatory matters and compliance. She also serves as the vice chair for the International Pharmaceutical Excipient Council (IPEC) Americas trade association qualification committee, acting as a liaison between regulatory bodies and excipient manufacturers and distributors.
Kapish Karan
Ashland global oral solid dosage r&d leader
At Ashland, global OSD R&D leader Kapish Karan is focused on pharmaceutical oral solid dosage, leading long-term innovation, and providing support for strategic customers. He has more than 10 years of experience in film-coating applications, the design of immediate—and modified-release coating products, and unit operations associated with the preparation of oral solid dosage forms.
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