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80 results of "Human Resources x" and "Documentation & Policy Mangement x"
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

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

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

Trends in FDA Compliance and Enforcement for Regulated Systems

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 ...

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 ...

On-Demand Webinar

21 CFR Part 11 Electronic Records and Signatures Compliance for Computer Systems Regulated by FDA

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 includes development of a company philosophy and approach, ...

Recorded Webinar

Artificial Intelligence (AI), Machine Learning, and the FDA

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...

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