Life Sciences Webinars

• 60 Mins

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federa...

By Internal Team

• 60 Mins

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particula...

By Internal Team

• 60 Mins

In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Compute...

By Internal Team

• 60 Mins

This webinar will include discussions, proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips o...

By Internal Team

• 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