Why Should You Attend:
An often overlooked aspect of pharmaceutical development and supply chain maintenance is the interplay between pharmaceutical dosage forms and their respective packaging. Along with control on the ingredients, both active and excipients, proper control of packaging is crucial to both developing an effective product and maintaining proper purity, efficacy and safety over the intended shelf-life. With the 2006 publication of the Product Quality Research Institute’s Safety Thresholds and Best Practices for Leachable and Extractables in Orally Inhaled and Nasal Drug Products (OINDP), the design and safety expectations for packaging compatibility studies was put on a sound scientific basis. Worldwide regulatory authorities now expect that similar scientific justifications be constructed for all dosage forms. This expectation has expanded in recent years to include any surface, even during processing, to be investigated and justified.
This webinar will begin with a discussion of the history behind the legal basis of pharmaceutical regulations in the US and EU. Recent regulatory trends with regards to packaging will also be discussed.
Upon completing this course, participants should understand:
Areas Covered in the Webinar:
Who Will Benefit:
This course is designed for pharmaceutical professionals tasked with developing or controlling pharmaceutical packaging systems including those who have no prior experience. Key organizational roles may include QC, Regulatory or Quality Management Systems responsibilities such as:
Thomas N. Feinberg, Ph.D., President, SCĪO Analytical, LLC - He founded SCIO Analytical in 2014 as a science-based consulting resource focused on helping clients find solutions for difficult analytical chemistry problems such as extractables and leachables. Prior to SCIO Analytical, Dr. Feinberg worked for four years at the University of North Carolina at Chapel Hill in Chemistry and Environmental Sciences followed by a two-decade career at the Morrisville, North Carolina site of Catalent Pharma Solutions (formerly Cardinal Health and Magellan Laboratories). As the first LC-MS chemist at Magellan, he grew the Structural Chemistry function to become the industry leader in CMC support laboratory services impurity and degradant investigations and developed one of the premier laboratories for extractables and leachables studies across all dosage forms. Dr. Feinberg is internationally recognized, serving as an active member of the Product Quality Research Institute (PQRI) since 2001 and as the trainer for the 2006 PQRI Orally Inhaled and Nasal Drug Product Extractables and Leachables process. He has been a science advisor to the Materials Working Group of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS) since 2012. At SCIO Analytical, Dr. Feinberg has assisted clients with designing and remediating quality control and assurance systems for drug substances, drug products, containers and novel manufacturing processes. He has worked with clients on successful regulatory filings across all phases of development. Dr. Feinberg completed his bachelor’s degree in Chemistry at Cornell University and his doctorate in Physical Chemistry at the University of North Carolina at Chapel Hill.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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