All FDA Regulated Industry Webinars

• 60 Mins

FDA and regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biolo...

By Internal Team

• 60 Mins

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics...

By Internal Team

• 60 Mins

Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilit...

By Internal Team

• 60 Mins

This webinar will discuss the types of FDA audits and why they occur, the Do's and Don'ts during an FDA inspection, how to properly answer questions from an inspector, the significance of 483s and warning...

By Internal Team

• 60 Mins

This webinar describesAs part of the Case for Quality program US FDA noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention towa...

By Internal Team

• 60 Mins

IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device product...

By Internal Team

• 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

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