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168 results of "Multi Industry x" and "Training & Development x"
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

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

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

The GCPs/GLPs/GMPs: Comparison and Understanding of the FDA’s 3 Major Regulations

This webinar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how  basic Quality Management System (QM ...

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

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

Boot Camp on the Quality Management System (QMS) – Per ISO and US FDA’s GMPs

This webinar is focused on the workings of the Quality Management System, what is required of a compliant system according to ISO 9001, and the QMS audit. This seminar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ...

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