All FDA Regulated Industry Webinars

• 60 Mins

This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and do...

By Internal Team

• 60 Mins

Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements but al...

By Internal Team

• 60 Mins

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a...

By Internal Team

• 60 Mins

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product...

By Internal Team

• 60 Mins

Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process t...

By Internal Team

• 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 From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end-users, assays need to switch betwe...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