All Virtual Course! 12 Contact hours, 4 teaching hours per day, + 1/2 hour break each day.
IPEC-Members will receive a substantial discount for the workshop.
Excipients often play a critical role in the manufacture of bio/pharmaceuticals and in the formulation of small molecule and biotherapeutic products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states: “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.”
Compliance with compendial requirements is a legal and regulatory requirement in those countries in which a pharmacopoeia is specified. While there is good awareness of compendial requirements for drug products and APIs, there is less understanding by excipient manufacturers related to confirmation the excipient meets the pharmacopoeia monograph.
This comprehensive 12-hour, accredited course has been developed and is presented through the joint efforts of the International Pharmaceutical Excipients Council (IPEC) and the Center for Professional Advancement (CfPA). The training includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF and Ph. Eur. With the IPEC-Americas/CfPA collaboration, a global perspective which touches on other the pharmacopoeias, with an emphasis on the USP-NF and Ph. Eur. A global perspective which touches on other pharmacopeias is presented. Details of the content, organization and use of the pharmacopoeias are covered, along with regulatory considerations for excipients. The course reviews practical examples of compliance with compendial requirements, as published by pharmacopoeias. In addition, there is exploration of the development and revision processes for compendial monographs with real-life case studies, along with a review of efforts toward compendial harmonization by IPEC, the Pharmacopoeial Discussion Group (PDG), and the International Council for Harmonisation (ICH). Thhe course concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and ultimately, compliance with the requirements in the pharmacopoeias.
The course will assist the global bio/pharmaceutical industry, including innovator, generic, biotechnology, Contract Manufacturer, and consumer-care companies, seeking greater understanding of compliance requirements for excipient suppliers, particularly with the USPNF and Ph. Eur.
NOTE: Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.
Who Should Attend
This course is intended for those responsible for ensuring compliance of excipients with the pharmacopoeias and regulatory authorities and is applicable to pharmaceutical and excipient manufacturers and excipient distributors within the OTC, generic, innovator, biotechnology, consumer-care, and related industries. This course will benefit individuals in:
> Compendial affairs
> Regulatory affairs/CMC
> Quality assurance/Quality Control
> Analytical Chemistry
> R&D/product development/Formulation/Method development
> Product management/marketing