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 …
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 …
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 …
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 …
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 …
The Biotility office will be closed Monday, January 20th in observance of Martin Luther King, Jr. Day.
We will reopen with our regular hours on Tuesday.
This will close in 12 seconds
