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435 results of "Life Sciences x"
Live Webinar

The 6 Most Common Problems in FDA Software Validation and Verification

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

Live Webinar

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Medical device manufacturing plants, required to follow 21 CFR ...

  • Basic & Intermediate
  • 60 Mins
  • José Mora
  • Nov 19, 2019
Live Webinar

Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)

Outline of the relevance of information from the CMC perspective Understanding differences between small molecules and Biologics Glimpse of CFR 312.22 with the highlight on the FDA’s primary objectives in reviewing an IND Overview of Pre-IND activities C ...

Live Webinar

FDA’s Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

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

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 th ...

  • Basic & Intermediate
  • 60 Mins
  • José Mora
  • Nov 20, 2019
Live Webinar

Backup Communications for Medical Facilities – New Federal Regulations Affect Healthcare Providers and Amateur Radio

Amateur Radio’s primary purpose for existing is to provide backup communications in times of disaster. The webinar presents methods used to provide communications when Internet and Phone Systems are not accessible due to human-made or natural disasters.

Live Webinar

FSMA Preventative Controls for Sanitary Transport For Logistics Professionals

Aside from regulatory requirements, liability for the safety of an organization’s food products will be covered. The importance of documentation control is critical in this area.

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Nov 21, 2019
Live Webinar

On-boarding in a GMP Environment: Best Practices for Foundational Employee Success

The objective of the course is to enable attendees to: Define the onboarding process in the context of regulatory compliance Interact with Human Resources to create a coordinated onboarding strategy that covers both their requirements and quality requireme ...

Live Webinar

HACCP - How To Create A HACCP-Concept And How To Deal With CP's And CCP’s?

The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintain HACCP files documentation and find and define the checkpoints (CP) and critic ...

Live Webinar

FDA Best Audit Behavior Practices – Do’s and Don’ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...