Quality Assurance
BIOL-40342
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 Information
Course sessions
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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.
Textbooks:
All course materials are included unless otherwise stated.
Policies:
- No refunds after: 4/7/2025
Schedule:
Instructor: James Stumpff
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 challenges that different companies face.
Jim's influence extends beyond his professional roles. He is a recognized thought leader in the industry, evidenced by his contributions such as publishing industry articles and presenting at numerous conferences. His insights and knowledge have contributed significantly to shaping the discourse around regulatory practices in the biopharmaceutical and medical device field.
