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339 results of "Life Sciences x"
Live Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

Live Webinar

USING A SUPPLIER RATING SYSTEM

How do you know how well your suppliers are doing?  Most responses present a subjective view.  It is akin to throwing darts - sometimes you are close, but most times you are "off-target". You need a tool that will provide an objective, quantitative visibility ...

Live Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

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Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance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

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...

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

SUPPLIER/VENDOR-MANAGED INVENTORY

Supplier/Vendor Managed Inventory is a program that optimizes supply chain performance.  The supplier and the customer learn to operate in a mutually beneficial manner that provides financial gains as well. It is a process for resupplying inventory in an expe ...

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 ...