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Live Webinar

AI in Drug Development

The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry. Artificial ...

Live Webinar

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.  The ...

Live Webinar

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.  This webinar will help you understand the FDA’s current thinking on vendor audit ...

Live Webinar

How to Prepare for and Host an FDA Inspection and respond to 483s

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, f ...

Live Webinar

Medical device cybersecurity following 2025 FDA Pre-market Guidance

This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated. Concepts from the 2025 Guidance will be explained. The cybersecurity program must be carefull ...

Live Webinar

Through the Eyes of an Auditor

An external auditor is coming to your plant.  Their first impression may have a major impact on your plant's future as well as your own career.  How will your plant look to that auditor? Before they even set foot in the door - what your grounds and outside fa ...

  • Intermediate
  • 60 Mins
  • Jose Mora
  • Sep 16, 2025
Live Webinar

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environme ...

Live Webinar

The Latest FDA Q-Sub Final Guidance

This webinar will discuss the US  FDA’s Final Guidance on the Q-Submission Program, dated May 29, 2025, which addresses how to request interactions with the FDA related to future medical device submissions. This allows companies and the FDA to arrive at mutual ...

Live Webinar

Employer and Payroll Updates due to OBBBA 2025

On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...

Live Webinar

Data Governance for Computer Systems Regulated by FDA

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...

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Validity : 24th Aug'25 to 03rd Sep'25