US Laws, Regulations and Industry Best Practices for Excipients
Part 1: Wednesday, October 20, 2021 - 9:00am to 11:00am EDT Part 2: Thursday, November 4, 2021 - 9:00am to 11:00am EST This webinar is intended to provide a road...
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Novel Excipient Review Pilot Program Overview and Q&A
Wednesday, October 27, 2021 The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program),...
Overview of Excipient Laws and Regulations in Europe
Tuesday, November 16, 2021 - 9:00am to 11:00pm EST This webinar is intended to provide a road map for how the regulatory process in Europe works relative to the use...
Excipient GMP Certification Scheme and Certification Body Qualification
Thursday, November 18, 2021 - 10:00am to 11:00pm EST This FREE webinar is intended to provide an overview for use and value of the recently published IPEC GMP...
UPDATED Excipient GMP Compliance Virtual Workshop
November 29 – December 3, 2021 Compliance with excipient GMP/GDP is important to everyone (not just auditors) involved in the manufacture, distribution or use of...
Recording: Excipient Stability – Use of expiration/retest dates and accelerated aging
Wednesday, September 29, 2021 - 10:00am to 12:00pm EDT Excipient stability regulations are different than that of drug product and API, but have similar expectations.
Recording: Best Practices for Communicating Nitrosamine Strategies Between Makers and Users
August 31, 2021 11:00am to 1:00pm EDT Nitrosamines and related compounds continue to be a hot topic among regulatory agencies globally.
Recording: Validation for Pharmaceutical Excipients Presented by The International Pharmaceutical Excipients Council
July 21, 2021 (9:00 AM - 11:00 AM Eastern) The IPEC Validation Guide for Pharmaceutical Excipients issued in January 2021.
The Importance of Excipient Functionality Webinar
Recording from June 9, 2021 There is increasing awareness of the important role that excipient functionality plays in drug formulations, both in existing and in new...
Excipients & Upstream/Downstream Manufacturing Processes in Biologic Drug Products Recording
Recording from Wednesday, June 30, 2021 The growth in biologic drug development has been dramatic in the last 10 years and is set to continue in the future....
Innovations in Pharmaceutical Coating Development
Recording from Wednesday, May 12, 2021 Webinar Overview There have been some major advances over the last 20 years in the use of polymeric excipients for film...
Role of Excipients in Continuous Manufacturing of Solid Oral Dosage Forms
Recording from Wednesday, April 21, 2021 Continuous manufacturing is a hot topic within the pharmaceutical industry and with the FDA. Pharmaceutical companies are...
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...
Incorporation of Pharmaceutical Excipients into a Quality-by-Design (QbD) Development Project - NEW IPEC GUIDE Webinar
Recording from Wednesday, January 13, 2021 Do excipient unknowns derail your drug development project? What you don’t know about your excipients might surprise...
Best Practice Considerations for Efficient and Effective Virtual Audits
Recording from Wednesday, December 2, 2020 The presentation focused on: Most on-site audits of excipient suppliers have been suspended (deferred) due to the...