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124 results of "Human Resources 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 ...

Live Webinar

Develop a Product Risk Management File (ISO 14971, always required), and a Human Factors / Use Engineering File (IEC 62366-1, as required)

Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Pro ...

On-Demand Webinar

ChatGPT / AI and Project Management for FDA-Regulated Companies

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...

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