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188 results of "Life Sciences x" and "Medical Devices x"
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 regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...

Live Webinar

The Transfer of Validated Methods

This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Dec 05, 2022
Live Webinar

Outsourcing Software Development for Medical Devices

This webinar will discuss the skillsets to look for when outsourcing, how to know if the work is compliant (without having to be an expert in software development), how to manage outsourced development, and your responsibilities throughout the product lifecycl ...

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.

Live Webinar

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Dec 19, 2022
Live Webinar

How to Deal with Bad Results Under GLP

Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Jan 04, 2023
Live Webinar

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy and approach and incorporating it into an overall computer syst ...

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
  • Jan 18, 2023
Live Webinar

Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...

Live Webinar

Vendor Audit for Systems and Services for FDA-Regulated Systems

This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...