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152 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

Advertising and Promotional material compliance and review process

The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...

Live Webinar

FDA Case Scenarios – Best Practices for Managing Inspection Situations

Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real li ...

Live Webinar

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...

Live Webinar

FDA Compliance and Mobile Applications

We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system do ...

Live Webinar

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation - The Requirements

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR.  It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technica ...

Live Webinar

How to Properly Investigate OOS Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

Live Webinar

Top Process Validation Mistakes - And How to Avoid Them

Validation is an important element of the Quality System Regulations and ISO13485.This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.You’ll learn t ...

Live Webinar

How to Implement an Effective Human Error Reduction Program

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. For example;  The CFR - Code of Federal Regulations Title 21 Subpart B_Organizat ...

Live Webinar

Using Kanban JIT Systems to Run a Startup Plant

Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also, attendees will learn elements of lean documents and lean configuration, sterilizatio ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Sep 12, 2019
Live Webinar

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ...