This course focuses on the systems and oversight role of quality assurance professionals in the pharmaceutical industry. Students will understand the components of Pharmaceutical Quality Management, roles and responsibilities of quality (QA/QC), Quality by Design (QbD), documentation management, supplier management, and quality risk management.
Course Number: BIOL-40342
Credit: 3.00 unit(s)
Related Certificate Programs: Quality Assurance and Control
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4/1/2024 - 6/10/2024
$725
Online
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CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
INSTRUCTOR:
Stumpff, James (1)
Jim is currently holding the position of Executive Director of Quality at Adamis Pharmaceuticals in San Diego, CA. In this role, he assumes responsibilities for overseeing quality assurance, regulatory affairs, and pharmacovigilance. With a combined experience of over 30 years in FDA and Industry biopharmaceutical and medical device regulatory and compliance sectors, Jim brings a wealth of expertise to his current position. Previously, he held the role of Principal Consultant at Parexel International for a decade. During this time, he provided strategic guidance and solutions to a diverse range of clients, which included small start-ups as well as large global organizations. This experience equipped him with a comprehensive understanding of the intricate regulatory and compliance c...Read More
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POLICIES:
No refunds after: 4/8/2024.
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4/1/2024 - 6/10/2024
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or unex-sciencetech@ucsd.edu for information about when this course will be offered again.