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58 results of "Multi Industry x" and "Investigations & Audits x"
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

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

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 ...

Live Webinar

Developing and Implementing Quality Culture in the Organization and Why it’s Important

In today's regulatory landscape, a strong quality culture is essential for preventing compliance issues and ensuring consistent product quality. Regulatory bodies, including the FDA, increasingly emphasize the need for organizations to establish and maintain a ...

Live Webinar

DHF (Design History File),DMR, DHR, Technical Documentation Files – US FDA and EU MDR Requirements

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

Live Webinar

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to ...

Live Webinar

Project Management for Computer System Validation (CSV) to Improve FDA Compliance

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data in ...

Recorded Webinar

Best Practices in Preparation for an FDA Computer System Audit

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 computer syst ...

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