Role of Excipients in Continuous Manufacturing of Solid Oral Dosage Forms
April 21, 2021 (11:00 AM - 1:00 PM Eastern) Continuous manufacturing is a hot topic within the pharmaceutical industry and with the FDA. Pharmaceutical companies...
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UPDATED Excipient GMP Compliance Virtual Workshop
Compliance with excipient GMP/GDP is important to everyone (not just auditors) involved in the manufacture, distribution or use of excipients. This workshop includes...
Innovations in Pharmaceutical Coating Development
May 12, 2021 (11:00 AM - 1:00 PM Eastern) There have been some major advances over the last 20 years in the use of polymeric excipients for film coating in solid oral...
The Importance of Excipient Functionality
June 9, 2021 (11:00 AM - 1:00 PM Eastern) There is increasing awareness of the important role that excipient functionality plays in drug formulations, both in...
Excipients & Upstream/Downstream Manufacturing Processes in Biologic Drug Products
June 30, 2021 (11:00 AM - 1:00 PM Eastern) The growth in biologic drug development has been dramatic in the last 10 years and is set to continue in the future....
Microplastics Webinar Part 2 – Continued Issues and Impact on Pharmaceutical Products
Recording from Wednesday, February 17, 2021 The European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in...
IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients
Recording from Tuesday, November 17, 2020 The presenters provided an overview of the soon-to-be-published IPEC GMP Certification Scheme and Certification Body...
Regulatory Requirements for Excipients Used in Drugs for the India Market
Recording from Tuesday, October 13, 2020 This Webinar provided an overview of current excipient related regulations in India for the domestic and export markets...
Vision for FDA’s Inactive Ingredient Database in 2020 and Beyond
Recording from Wednesday, September 16, 2020 Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate...
Good Distribution Practices and Buying Through Distributors
Recording from Wednesday, August 26, 2020 Discussed why chemical ingredient distributors are an essential segment of the supply chain - providing excipients to...
Novel or Not? Our Inadvertent Journey Filing a Novel Excipient
Recording from Wednesday, July 22, 2020 This webinar was a first-hand account of the challenges to realizing, determining, and confirming the novel status of an...
Key New IPEC Position Papers and Guides: What You Need to Know!
Recording from Wednesday, June 24, 2020 This webinar will reviewed the recently re-issued IPEC Excipient Information Package User Guide and Templates. This guide is...
The Importance of Excipients in Continuous Manufacturing
Recording from Wednesday, April 22, 2020 The presenters provided > A high-level overview of continuous manufacturing including efforts and status for ICH > Q13...
Back by Popular Demand: Untangling the Confusion About What Excipient Suppliers and Users Need to Know About Nitrosamines and Excipients
Recording from Tuesday, April 7, 2020 Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and...
PDA and the IPEC Federation Publish Technical Report No. 54-6: Formalized Risk Assessment for Excipients
Recording from Wednesday, March 25, 2020 Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and...