We're here when you need us! While you can always reach us for questions by phone, twice a week Biotility staff has open office hours on Zoom where we can answer any questions you …
This lecture-based, 3-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory compliance, and maintaining a culture of quality …
We're here when you need us! While you can always reach us for questions by phone, twice a week Biotility staff has open office hours on Zoom where we can answer any questions you …
Current Good Laboratory Practices (cGLP) are federal regulations set in place to ensure investigational new drugs are safe before testing in humans. They are required when conducting preclinical studies to …
Current Good Manufacturing Practices (cGMP) are federal regulations followed by drug manufacturing companies to ensure their products are safe and effective for humans. Educators will learn the core precepts of …
In this lecture-based, three-hour live online course, participants learn the core precepts of FDA’s current Good Manufacturing Practices and their direct application to the manufacture and testing of a regulated …
Good Documentation Practices (GDP) are regulatory guidelines that help drug manufacturing companies maintain a system of controlled documents. GDP ensure proper recording, reporting, and archiving of everything involved in the …
This lecture-based, three-hour live webinar covers FDA's current Good Laboratory Practice (cGLP) regulations and how they affect the conduct of nonclinical laboratory safety studies. This course introduces the various elements …
Corrective Action Preventive Action (CAPA) is a process used by biomanufacturing companies to investigate, solve, and prevent problems with the goal of minimizing mishaps. This course will outline the CAPA …
In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial …
