Webcasts

Webcasts are recorded versions of (past) live webinars. To purchase a webcast please click on the title(s) you are interested in below.

Originally aired:
Wednesday, September 16, 2020 - 11:00am

In this presentation, FDA has identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020.

Originally aired:
Wednesday, August 26, 2020 - 11:00am

Discussed why chemical ingredient distributors are an essential segment of the supply chain - providing excipients to developers and manufacturers of drug products.

Originally aired:
Wednesday, July 22, 2020 - 11:00am

This webinar is a first-hand account of the challenges to realizing, determining, and confirming the novel status of an inactive ingredient in a Phase III Clinical drug product.

Originally aired:
Wednesday, July 8, 2020 - 11:00am

Dr. Hartung discussed revolutionary changes in how we predict human safety by assessing biological effects of chemicals in novel ways.

Originally aired:
Wednesday, June 24, 2020 - 11:00am

IPEC-Americas members have been busy while quarantined, and several new guides and position papers have been finalized.

Originally aired:
Wednesday, June 17, 2020 - 11:00am

This webinar was designed to help participants understand the underlying science behind the unpredictable in vivo performance of enteric coated formulations.

Originally aired:
Wednesday, May 20, 2020 - 9:00am

This webinar focused on current and emerging CFDA regulatory activities in China related to the use and approval of excipients.

Originally aired:
Wednesday, April 22, 2020 - 11:00am

This webinar provided a high-level overview of continuous manufacturing including efforts and status for ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline.

Originally aired:
Tuesday, April 7, 2020 - 11:00am

Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and elsewhere.

Originally aired:
Wednesday, March 25, 2020 - 9:00am

The new joint PDA IPEC risk assessment for excipients technical report has recently been published.

Originally aired:
Thursday, March 12, 2020 - 11:30am

A comprehensive overview of Excipient World 2020… and walk away with a clear understanding of why you should attend!

Originally aired:
Thursday, February 20, 2020 - 11:00am

This webinar addressed the impact of multi-sourcing of excipients on the manufacture, quality, safety, and  efficacy of drug products.

Originally aired:
Wednesday, January 22, 2020 - 11:00am

The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit.

Originally aired:
Friday, January 17, 2020 - 10:30am

A comprehensive overview of Excipient World 2020… and walk away with a clear understanding of why you should attend!

Originally aired:
Tuesday, November 19, 2019 - 8:00am

Review of the regulations and guidelines which apply to pharmaceutical excipient use in primary Latin American countries (e.g. Brazil, Argentina, MERCOSUR, Andes, Mexico).

Originally aired:
Wednesday, August 21, 2019 - 11:00am

Elemental Impurities: Filing experiences and the FDA

Originally aired:
Wednesday, July 24, 2019 - 11:00am

This webcast provides an overview of microplastics and highlights issues that both users and makers can consider when submitting individual company responses to ECHA.

Originally aired:
Thursday, June 27, 2019 - 11:00am

The webinar introduces the United States Pharmacopeia (USP) and their standards and programs. 

Originally aired:
Wednesday, March 27, 2019 - 11:00am

Webinar recording from March 27, 2019. The new topic will address regulatory practices regarding inactive ingredients used in cosmetics, food, dietary supplements and pharmaceuticals.

Originally aired:
Wednesday, March 20, 2019 - 11:00am to 12:00pm

The FREE one hour webinar will review FAQs regarding Excipient World 2019. There will be plenty of time for questions! 

Originally aired:
Wednesday, February 13, 2019 - 11:00am

Titanium dioxide (TiO2) E171 has been proven to be safe for use in food and pharmaceutical applications by many studies over the years.

Originally aired:
Wednesday, December 12, 2018 - 11:00am to 1:00pm

The recorded webinar will explain how to utilize all existing IPEC guidelines, programs and proposals to build an overall quality assurance system for excipients. 

Originally aired:
Tuesday, November 13, 2018 - 11:00am

The webinar will provide an overview of excipient composition & complexity.

Originally aired:
Wednesday, October 10, 2018 - 11:00am

This webinar will survey the recent regulatory findings concerning data integrity. 

Originally aired:
Wednesday, September 12, 2018 - 11:00am

This webinar will review the issues surrounding technically unavoidable particles (TUP) and explain how the TUPPs guide can be used for evaluating visible particles in excipients.

Originally aired:
Wednesday, July 18, 2018 - 11:00am to 1:00pm

The DMF Guide Overview - the main focus of the Guide is for U.S. Type IV (excipient) DMF content, format, filing, and review.

Originally aired:
Wednesday, June 13, 2018 - 11:00am

Ralph Lindblad presents: Auditing to Monitor the Excipient Manufacturer; Partnering for success; building relationships with the supplier and excipient assessors. 

Originally aired:
Tuesday, May 15, 2018 - 11:00am

Review of IPEC-Americas most recently updated Significant Change guide.

Originally aired:
Wednesday, March 14, 2018 - 11:00am

This webcast will discuss the importance of additives, impurities and concomitant components to excipient function.

Originally aired:
Tuesday, February 13, 2018 - 11:00am

This webcast is an overview of the IPEC guide Quality Agreement Guide and Template(s) for Pharmaceutical Excipients 2017

Originally aired:
Wednesday, January 17, 2018 - 11:00am

This webcast is an overview of the IPEC guide Qualification of Excipients for use in Pharmaceuticals.

Originally aired:
Wednesday, November 8, 2017 - 11:00am to 1:00pm and Thursday, November 9, 2017 - 11:00am to 1:00pm

Hear firsthand from the IPEC experts who helped develop the Excipient GMP standard, NSF/IPEC/ANSI 363!

Originally aired:
Wednesday, October 11, 2017 - 11:00am to 1:00pm

This webinar will provide excipient users with specific, practical advice on the implementation of elemental impurities requirements for finished dosage forms.

Originally aired:
Wednesday, September 20, 2017 - 11:00am to 1:00pm and Thursday, September 21, 2017 - 11:00am to 1:00pm

Co-sponsored by IPEC-Americas and the Center for Professional Advancement (CfPA); partners in training and education (T&E).

Originally aired:
Thursday, August 3, 2017 - 11:00am to 1:00pm

Confused by the various excipient GMP standards, schemes and guides? This webcast will set you straight about NSF/IPEC/ANSI 363 Excipient GMPs, EXCiPACT™, and the IPEC-PQG GMPs.

Originally aired:
Wednesday, May 24, 2017 - 11:00am to 1:00pm

This webinar will survey the recent regulatory findings concerning data integrity.

Originally aired:
Wednesday, April 19, 2017 - 11:00am

This is a practical introduction to the whys and how-tos of conducting risk assessments for excipients.

Originally aired:
Wednesday, March 15, 2017 - 11:00am to 1:00pm

This webinar will present an overview of nanotechnology - what is it, why is it important, and examples of its current use in the pharmaceutical and other industries.

Originally aired:
Friday, March 3, 2017 - 11:00am to 11:30am

(FREE) Find out how the IPEC-Americas Excipient Learning Lab can significantly improve your excipient training and education return on investment (ROI).

Originally aired:
Wednesday, January 18, 2017 - 11:00am

Gain the knowledge and skills to develop, compile, and communicate validation documentation that meets the needs of the customer and the requirements of the standard.

Originally aired:
Wednesday, December 14, 2016 - 11:00am to 1:00pm

Learn how IPEC is helping excipient makers, distributors, users and regulators develop a system of Total Excipient Control.

Originally aired:
Wednesday, October 19, 2016 - 11:00am to 1:00pm

This webinar is designed to facilitate all aspects of excipient resale including the application of the ANSI Excipient GMPs to distributors.

Originally aired:
Wednesday, September 14, 2016 - 11:00am to 1:00pm and Thursday, September 15, 2016 - 11:00am to 1:00pm

Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.

Originally aired:
Wednesday, May 4, 2016 - 11:00am to 1:00pm

ICH Q3D Guideline for Elemental Impurities became effective June 2016. Learn from the excipient experts how this will impact your company as a maker or user.

Originally aired:
Wednesday, April 13, 2016 - 11:00am to 1:00pm

What are Atypical Actives and How Should They be Regulated: GMP and Regulatory Filing Implications

Originally aired:
Wednesday, May 6, 2015 - 11:00am to 1:00pm

Review issues surrounding technically unavoidable particles and the role of the TUPP guide in supporting a risk-based approach for evaluating visible particles in excipients.