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264 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

Avoiding 483s throughout your organization - strategies, risk and mitigating approaches

Certainly, the most simplistic solution to achieving compliance excellence and 483 avoidance is “to do the right things right!” But what does this really mean?   I have distilled the “doing the right things right” solution into 7 separate individual keys or ...

Live Webinar

FDA Regulation of Artificial Intelligence - Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...

Live Webinar

Intro to Proper Aseptic Technique and Clean room Behaviour

In sterile compounding, the aseptic technique contributes to the prevention of microbiological contamination.  It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. Cleaning, Gowning, and proper methods ...

Live Webinar

Remediation - Resolve Root Causes of Compliance Issues

Understanding the Importance of Remediation: We will explore the significance of resolving root causes and how it can help organizations achieve sustainable compliance, mitigate risks, and maintain a robust ethical framework. Identifying Root Causes: Learn ho ...

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, ...

Live Webinar

CGMP Manufacturing Methods - PPC and SPC

This webinar will define what are the US FDA's expectations for the use of statistical techniques, e.g., 21 CFr 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justificatio ...

Live Webinar

FDA - ICH Guideline Q9 R1 on Quality Risk Management

The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...

Live Webinar

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Dec 07, 2023
Live Webinar

Using Excel Vlookup, Hlookup, Xlookup, Match, and Index

In Excel, sometimes there is a need to look up information from a table or from a different sheet, or to link the sheets together. 

  • Basic & Intermediate
  • 60 Mins
  • Tom Fragale
  • Dec 07, 2023
Live Webinar

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.