All FDA Regulated Industry Webinars

• 60 Mins

Effective problem-solving is a cornerstone capability for any professional aiming to achieve success and sustainable improvements within their organization. While issues and challenges are inevitable in a...

By Internal Team

• 60 Mins

Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the...

By Internal Team

• 60 Mins

Revolutionizing CSV: Embracing Critical Thinking, Risk Analysis, and Cutting-Edge Tools in an Evolving Tech LandscapeDemonstration of Risk Assessment ConceptsDemonstration of Risk Assessment Tools and Str...

By Internal Team

• 60 Mins

Computer Systems Validation (CSV) and Computer Software Assurance are both crucial aspects in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and e...

By Internal Team

• 60 Mins

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This inc...

By Internal Team

• 60 Mins

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology...

By Internal Team

• 60 Mins

For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s). And there’s no sign that things are getting any better....

By Internal Team

• 60 Mins

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on...

By Internal Team

• 60 Mins

FDA inspections are not just routine regulatory encounters — they are high-stakes, high-visibility events that can impact your organization's reputation, product pipeline, and commercial success. Whether...

By Internal Team