CGMP for Dietary SupplementsCertificate Short CourseCourse Description The FDA regulates both finished dietary supplements and dietary ingredients to ensure they are appropriately labeled, and safe for the consumer. Described in …
Good Documentation PracticesCertificate Short CourseCourse Description Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants will learn …
Regulatory Approval for Medical DevicesCertificate Short CourseCourse Description The Food and Drug Administration is responsible for ensuring that medical devices are safe and effective for their intended uses before they …
Corrective Action Preventive ActionCertificate Short CourseCourse Description This course will cover the CAPA system; the tools used to identify the root cause of deviations, methods used for root cause analysis, …
CGMP for Biopharmaceutical Drug Products (Live Online)Certificate Short CourseCourse Description This lecture-based, three-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing …
Navigating the Pre-IND Pathway (Asynchronous Online)Certificate Short CourseCourse Description In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug …
Navigating the Pre-IND Pathway (Live Online)Certificate Short CourseCourse Description In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the pre-Investigational New Drug …
Teaching Good Manufacturing Practices (cGMP) as a Workplace SkillIntegrating cGMP into Bioscience CurriculaCourse Description Current Good Manufacturing Practices (cGMP) are federal regulations followed by drug manufacturing companies to ensure their …
cGLP for Nonclinical Laboratory Studies (Live Online)Certificate Short CourseCourse Description This lecture-based, 3-hour live webinar covers FDA's current Good Laboratory Practice (cGLP) regulations and how they affect the conduct of …
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