This webinar will provide an overview of excipient composition and complexity. In this Quality by Design age and the need for enhanced understanding, excipients are coming under increasing scrutiny. After a brief introduction, the webinar will show how even minor components can have a significant impact on the finished pharmaceutical product. The webinar will be of interest to both excipient users and suppliers (excipient manufacturers, and distributors).
- For excipient users, it will provide insights into how excipients should be considered in the context of Quality by Design.
- For excipient suppliers, the webinar will provide indications as to the types of questions on excipient composition they can anticipate from customers in future.
- Enhanced understanding of excipient composition and complexity
- Review the importance of communication between excipient manufacturers and users
- Discuss how minor components can have a significant impact on the finished pharmaceutical product.
- Discuss the characteristics of excipients are potential CMAs, and how they might be controlled
Dr. Moreton has over thirty years experience in the pharmaceutical industry, mainly as a formulation scientist developing a variety of different dosage forms, but also in QA/QC and Technical Support in excipients and drug delivery. Most recently, he has been responsible for the development of clinical and commercial drug products and associated analytical methods, working with clients, licensing partners and contractors.
Dr. Moreton has authored and co-authored scientific papers, articles and book chapters, and lectured extensively on excipients, drug delivery, preformulation and formulation at universities, training courses and symposia in the U.S., Europe and Japan. He is a past Chair of IPEC-Americas.
Brian Carlin is Director QbD/Regulatory at DFE Pharma. He previously worked at FMC, SmithKline Beecham & Richardson Vicks. He is a Fellow of the Royal Pharmaceutical Society, and holds honorary Professorships at DeMontfort University and University of Maryland.
He is the recipient of the 2014 IPEC One World Award for Regulatory Excellence, and the 2012 IPEC Foundation Award for Industry Research Achievement. He is the immediate past chair of the IPEC Americas QbD Committee.
He has a doctorate in Interfacial Rheology from London University, and a degree in Pharmacy from the University of Aston in Birmingham.