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211 results of "Life Sciences x" and "FDA Compliance x"
Live Webinar

Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the eff ...

Live Webinar

An Advanced Course on Lean Documents, Lean Configuration, and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Feb 16, 2023
Live Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role reversal between the test method and the product or process it is designed to detect.  For example, while a defect-free process is desirable, a test ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Feb 23, 2023
Live Webinar

Cloud and Software-as-a-Service (SaaS) Vendors: Approach to Validation for FDA-Regulated System

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.  Th ...

Live Webinar

Medical Device Trends in FDA Compliance and Enforcement

This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...

Live Webinar

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...

Live Webinar

Design Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis of the design specification, which becomes the design output.  Since design ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Mar 15, 2023
Live Webinar

Best Practices in Preparation for an FDA Audit of Regulated Computer Systems

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 computer sys ...

Live Webinar

Best Practices in Preparation for an FDA Audit of Regulated Computer Systems

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 computer sys ...

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, ...