Life Sciences Webinars

• 60 Mins

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on...

By Internal Team

• 60 Mins

FDA inspections are not just routine regulatory encounters — they are high-stakes, high-visibility events that can impact your organization's reputation, product pipeline, and commercial success. Whether...

By Internal Team

• 60 Mins

Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-...

By Internal Team

• 60 Mins

This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper...

By Internal Team

• 60 Mins

Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will lear...

By Internal Team

• 60 Mins

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your...

By Internal Team

• 60 Mins

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug pr...

By KELLY THOMAS

• 60 Mins

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the...

By Internal Team

• 60 Mins

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper...

By Internal Team