Search Trainings

181 results of "Life Sciences x" and "Medical Devices x"
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

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 ...

Live Webinar

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.Human errors start at the design stage.Fro ...

Live Webinar

Understanding Initial IND Submission- The first 30 days

This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...

Live Webinar

Proper CAPA Management

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...

Live Webinar

Avoiding Death by CAPA – What you need to know

CAPA is the foundation of an effective Quality Management System.  Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.  Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...

Live Webinar

Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries

Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, ...

Live Webinar

How to Write Sop'S that Avoid Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...