Biotility Office Hours
Online - Virtual MeetingWe'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, 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 …
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 …
Course Description This lecture-based, three-hour virtual course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (CGMPs), regulatory compliance, and maintaining a culture of …
This course covers the core principles of the 5S system, and illustrates why using 5S is essential to a “Lean” initiative. Topics include the foundations of the Lean system, structure …
Course Description This lecture-based, three-hour virtual course covers 21 CFR Parts 210, 211, and 600. Topics include Current Good Manufacturing Practices (CGMPs), regulatory compliance, and maintaining a culture of quality …
Research facilities are essential to discoveries and breakthroughs, and at times, an entire facility may be built to support the specialized instruments required for research.
Cleanrooms are controlled environments in which airborne and surface bound particles are limited based on the classification of the space. Maintaining particulate specifications requires specific behaviors and protocols, with the …
Participants learn the core precepts of FDA’s Current Good Manufacturing Practices (CGMP) and their direct application to the manufacture and testing of a regulated biological product.