PerkinElmer

https://www.pharmtech.com/pt_w/excipients

Excipient manufacturing and process development for its use in drug production must meet GMP compliance. The suitability of pharmaceutical excipients for their intended use is defined by critical quality attributes (CQAs) such as identity, strength, and purity, which can pose numerous analytical challenges due to the complex nature of excipients.

) provides continued guidance on how to specify excipient composition, including control of impurities. Further efforts from the International Council for Harmonization (ICH) are needed to set guidelines relating to the control of impurities in excipients. In this webinar, we will cover:

Challenges associated with the control of impurities in excipients

Analytical techniques used for the characterization of pharmaceutical excipients

Use of analytical technologies to drive the control of impurities in excipients

Understand the regulatory framework for excipients testing, with a viewpoint on the USP stimuli article, titled The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities.

Detect possible genotoxic impurities in excipients

Achieve data integrity by using software compliant to cGMP and 21 

Wednesday, April 28, 2021, 8AM PDT | 11AM EDT | 4PM BST | 5PM CEST

On demand available after final airing until April 28, 2022

Webcasts

***Wednesday, April 28, 2021, 8AM PDT | 11AM EDT | 4PM BST | 5PM CEST*** This webinar brings together experts from LGC and PerkinElmer to share their perspectives on addressing challenges in excipients testing, as well as providing insights and strategies for a successful path for the control of impurities in excipients to achieve 21 CFR Part 11 compliance.*** On demand available after final airing until April 28, 2022.***


Strategies to Simplify the Evaluation of Pharmaceutical Excipients

https://www.chromatographyonline.com/lcgc_w/extractables

Extractables and leachables (E&L) testing is an important area in medical device and medicinal products. Join us for this session to hear global industry and regulatory experts discuss current hot topics in E&L testing for pharmaceuticals, biopharmaceuticals, and medical devices. In this Covid 19 world there are urgent testing requirements to help battle this pandemic. This webcast will give you an insight to this ever-changing world of E&L.

Gain insight to some of the important E&L areas relevant to medical devices and pharmaceuticals, for both small and large molecules

Discover the importance of a team to solve E&L challenges: those with regulatory knowledge, toxicologists and analytical chemists.

Understand the science behind the testing

Dennis Jenke, Chief Executive Scientist, Triad Scientific Solutions, LLC

Douglas J Ball, MS, DABT, Managing Partner & Toxicologist, D&B ChemTox, LLC

William Beierschmitt, Managing Partner & Toxicologist, D&B ChemTox, LLC

James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy, Pall Biotech

Aaron Hineman, Inorganic Product Line Leader-Americas, PerkinElmer, Inc.

Nick Morley, Principal Scientist, Hall Analytical

Ron Brown, Toxicologist, Risk Science Consortium

Andrew Feilden, European E&L Strategic Director, Hall Analytical

: Wednesday, February 24, 2021 at 10am EST | 3pm GMT | 4pm CET

***Live: Wednesday, February 24, 2021 at 10am EST | 3pm GMT | 4pm CET***  Join global industry and regulatory experts as they discuss current E&L hot topics related to pharmaceuticals, biopharmaceuticals and medical devices. ***On demand available after final airing until Feb. 24, 2022***

The Ever-Changing World of Extractables and Leachables, Part 2 A Free Virtual Conference 

https://www.pharmtech.com/pt_w/cmc_testing_challenges

Regulators assess the chemistry, manufacturing, and control (CMC) section of a submission to determine if the drug product shows the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the finished dosage form.

This webcast will explore how impurities are addressed in investigational new drug (IND) applications, new drug applications (NDAs), and abbreviated new drug applications (ANDAs) in context to small-molecule manufacturing and quality controls and will also include United States Pharmacopeia’s (USP’s) guidance with biologicals.

With increasing trends to investigate clinical targets with multiple modalities, it is challenging to maintain access to analytical capabilities and capacity. This webcast will also explore a published four-quadrant work model and how the approach has evolved, resulting in a dramatic increase in both capability and capacity at reduced cost.

Review USP approaches to monitoring impurities, including a discussion on existing 

 standards and standards under development

Gain an overview of how impurities are addressed in INDs, NDAs, and ANDAs, in context of small-molecule manufacturing, including corresponding ICH and FDA guidelines

Enable operation of an efficient and sustainable product development organization

Learn how smart automation protocols, coupled with targeted project management tools and a strategic approach to insourcing, can vastly improve compliance, robustness, and turnaround times at a significantly lower cost compared to traditional work models.

Dr. Annu Uppal, Senior Manager, Scientific Affairs, South Asia, USP

Dr. Christian Zeine, Senior Manager, Scientific Affairs EMEA, USP

Brian Fahie, PhD, Senior Director, Product Technical Development, Biogen

Wednesday, November 18, 2020 at 10am EST | 9am CST | 3pm GMT | 4pm CET

On demand available after airing until Nov. 18, 2021

***Live: Wednesday, November 18, 2020 at 10am EST | 9am CST  | 3pm GMT | 4pm CET *** Scientific leaders from the United States Pharmacopoeia (USP) and Biogen share perspectives on addressing challenges in chemistry, manufacturing, and controls testing, and provide insights and strategies for a successful path from drug development to commercial manufacturing.***On demand available after airing until Nov. 18, 2021


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