Biotility Course Policies and Procedures
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 …