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171 results of "Manufacturing x" and "Quality Management System x"
Live Webinar

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested fi ...

Live Webinar

Design, develop, and Implement an Effective Line Clearance Program

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur.  Preventin ...

Live Webinar

How to Use Excel Pivot Tables

In just one fast-paced and informative training session, you'll learn how to use PivotTables better to sort, filter, and subtotal your data more efficiently create multiple customized reports in a few easy steps and gain a powerful new tool to help you make be ...

Live Webinar

Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

This interactive webinar explains how to configure and validate 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 ho ...

Live Webinar

Computer System Validation (CSV) for FDA-Regulated Computers

As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...

Live Webinar

Optimize Your Supply Chain: Leveraging 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

The Secrets of Outlook 365 Revealed Demonstrated in Outlook 365

In this webinar, you will learn to use little-known Outlook features and advanced features that are hiding in plain sight. Not only will you learn about the features, but you’ll learn the benefits of those features from a time management viewpoint. Effective ...

Live Webinar

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to make all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables. Many people struggle w ...

  • Basic & Intermediate
  • 60 Mins
  • Tom Fragale
  • Oct 19, 2023
Live Webinar

Design Control Requirements / Documents Under 21 CFR 820.30 and ISO 13485 7.3

This webinar will provide valuable guidance to regulated companies in the development and implementation of Design Control Planning and Techniques for new product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance ...

Live Webinar

Design Control for Medical Devices: Overview and Design Inputs

Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.