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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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May 03, 2012 |
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Center for Professional Innovation & Education (CfPIE), Berlin, Germany
Oct. 11 & 12, 2012
This two-day course is designed to give participants of all levels a strong foundation in the fundamentals of FDA regulatory compliance for drugs and biotech products. Additionally, this course will detail how to meet compliance objectives in a cost-contained manner. Upon completion of the course attendees will understand the guidelines, philosophy and practical approach to FDA compliance. Participants will have a firm grasp of the seven key strategies to cost-effective compliance, including the use of outsourced assistance, audits, simultaneous submissions, Quality by Design (QbD), use of operational definitions, reliance on electronic submissions, and prioritization of guidelines. All attendees will receive ample resources for reference.
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Organized by:
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Center for Professional Innovation & Education |
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Invited Speakers:
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Contact info@cfpie.com for a list of course instructors
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Deadline for Abstracts:
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n/a
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Registration:
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http://www.cfpie.com/showitem.aspx?productid=019&source=hummolgen
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E-mail:
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info@cfpie.com
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