The Challenge of Change – Managing Excipients Control
Excipients are rarely equivalent but may be interchangeable.
As a premier excipient supplier, Colorcon understands the challenges that notifications of change can bring, and that the true cost of managing excipient change can only be measured over the long term.
Although requalification of materials, inventory management and continuity of supply are considerations, the security of final product position in the market is crucial.
This webinar will review the obligations and expectations of the pharmaceutical industry faced by an excipient supplier in maintaining security long term, while minimizing the impact and actions required by you, in response to change notification.
Topics discussed will be:
Kevin J McGlue
CSci, CChem, MRSC
Director Global Quality Assurance, Colorcon Inc.
Kevin is currently responsible for Colorcon QA and QC activities worldwide. He was a member of the IPEC team that produced the 2001 revision of their Excipient GMP guide, and a member of the team responsible for the production of the latest joint IPEC / PQG Excipient GMP guide. He is also a past chair of the IPEC Europe GMP committee.
Director Regulatory Affairs, EMEA, Colorcon Limited.
Carl has over 30 years experience in QC/QA and Regulatory Affairs. He is an active member of the International Pharmaceutical Excipients Council (IPEC) Europe, as the Chair of the Quality and Regulatory Affairs Committee. He is also a member of the European Pharmacopoeia Working Party on Functionality Related Characteristics and a member of the British Pharmacopoeia Working Party on Excipients.