Search Trainings

103 results of "Life Sciences x" and "Biotech & Biologics x"
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

Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...

Live Webinar

Fair Debt Collection Practices Act (FDCPA)

The FDCPA is a federal act that provides consumers with information around debt collection. Third party debt collectors have to abide by the regulations

Live Webinar

US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...

Live Webinar

Risk-based Design Control - The New Paradigm for Medical Device Design

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.  Design control is not only a requirement of t ...

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
  • Jan 29, 2024
Live Webinar

Risk Management for Medical Devices per ISO 14971 2019

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consi ...

Recorded Webinar

Current GXP expectations on Water system validation compliance

The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...

Recorded 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 ...