Life Sciences Webinars

• 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

• 60 Mins

This presentation shall describe how to create Sampling Plans for verification and validation, production process validation, and production control. The webinar will include the theoretical background of...

By Internal Team

• 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

This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Fau...

By Internal Team