Life Sciences Webinars

• 60 Mins

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your perfo...

By Internal Team

• 60 Mins

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best positio...

By Internal Team

• 60 Mins

Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical...

By Internal Team

• 60 Mins

This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is requir...

By Internal Team

• 60 Mins

Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to un...

By Internal Team

• 60 Mins

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and complianc...

By Internal Team

• 60 Mins

A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and...

By Internal Team

• 60 Mins

The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and re...

By Internal Team

• 60 Mins

Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in th...

By Internal Team