Life Sciences Webinars

• 60 Mins

This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for m...

By Internal Team

• 60 Mins

Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from i...

By Internal Team

• 60 Mins

Laboratories need to transition technologies all of the time. From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end-users, assays need to switch betwe...

By Internal Team

• 60 Mins

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electr...

By Internal Team

• 60 Mins

This course is intended to provide specific guidelines for coaching attendees on the best practices for developing requirements for computer systems regulated by FDA. There are several key types of requir...

By Internal Team

• 60 Mins

We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of p...

By Internal Team

• 60 Mins

This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements...

By Internal Team

• 60 Mins

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problem...

By Internal Team

• 60 Mins

Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. A good QMS consists of standards and guidelines relating to thei...

By Internal Team