All Virtual Course! 12 Total Contact Hours = 4 teaching hrs. 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
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.
Joe Albanese is Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years’ experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As part of his duties, he was responsible for the compendial vigilance process for all Janssen products ensuring compliance with all major global and national pharmacopoeias. He actively served in industry working groups such as the PhRMA Limited Duration Key Issues Team for compendial issues with USP, the EFPIA Biotherapeutics subteam for the elaboration of biotherapeutic compendial standards and was a member of the USP General Notices Project Team. He is currently active in the industry trade organizations NJPQCA, Midwest Compendial Discussion group and PDA that influence global health and compendial authorities. He recently co-authored a comprehensive 12-part series of articles, with J. Mark Wiggins, on compendial compliance that were published in Pharmaceutical Technology and BioPharm International.