Medical Devices Webinars

• 60 Mins

Training programs have evolved. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though the training is considered the “vacci...

By Internal Team

• 60 Mins

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This inc...

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 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

• 60 Mins

This workshop will explore the topic of setting appropriate sampling plans and using those plans to set appropriate acceptance criteria for process validations. Using a 5 step method, the attendee will co...

By ALAN GOLDEN