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 currently serves as the Director of QbD for DFE Pharma. Brian Carlin is a Fellow of the Royal Pharmaceutical Society, and an honorary visiting Professor at DeMontfort University where he teaches on excipients for the distance learning MSc in QbD. 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 chairs the IPEC-Americas QbD Committee and the Excipient Composition Committee, and serves on the USP Excipient Committee. He is the former Director Open Innovation (Pharma) at FMC, and Global Manager Pharmaceutical R&D. He previously worked in new product development at SmithKline Beecham & Richardson Vicks. He has been a leading advocate for innovative scientific approaches to excipients and pharmaceutics in pursuit of the QbD vision of the 21st century cGMP initiative.