Why Should You Attend:
Global sourcing of raw materials and excipients, undertaken to reduce cost, has opened up the supply chain to increased risks and limited the ability to patrol it. This webinar will suggest a strategy to assess risk, as well as tactics to use in audits and supplier interactions. Should you do more testing? If so, what methods? More auditing? Where do you audit-- the basic manufacturer, the re-packager, or the vendor you purchase from? How does this potential expansion of due diligence get achieved when there is relentless cost pressure on your business?
Find out whether your audits and surveys actually help you to detect or prevent unsuitable materials from entering your product stream. Have you asked whether the routine QC testing, qualification 'full' testing, and other measures also include a look at intentional and unintentional adulteration? -About 100 people died after receiving heparin that was tainted; Many deaths have occurred in several separate events where diethylene glycol entered medicines; As a pharmaceutical firm, or a supplier of excipients, you are required to assure the traceability and suitability of all ingredients.
Areas Covered in the seminar:
Who will benefit:
This webinar will help pharmaceutical, biologics, and nutraceuticals firms learn how to mitigate their risk. Excipient suppliers can gain insight into their customers' requirements, and explore their supply chains for risk and risk mitigation potential.
Paula Shadle, Ph.D., a quality and process development consultant has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, over 45 publications and 4 process patents. Is a member of the Parenteral Drug Association, the American Chemical Society, the Association for Women in Science, and the California Separations Society (CaSSS). Dr. Shadle has provided GMP training for numerous firms as well as the University of Wisconsin, and gives frequent audio seminars.
Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California and postdoctoral training at the Max-Planck Institute in Germany. She held technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting in 2001.
Shadle Consulting offers consulting services for biopharmaceutical firms in process development, CMC, and quality systems. Services provided include QA audits, GMP training, QC laboratories, and IND/BLA support. Experienced with clinical trials production, process validation, and more.
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.If you have any concern about the content of the webinar and not satisfied 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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