Search Trainings

99 results of "Manufacturing x"
Live Webinar

21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Live Webinar

ETHICS: BEST PRACTICES AND DECISION MAKING

This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties.  We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...

Live Webinar

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...

Recorded Webinar

Technical Writing: A Detailed Process

Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...

Recorded Webinar

Ten Keys for Maximizing the Benefits of your SPC Program

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.  However, not all SPC pro ...

Recorded Webinar

Fundamentals of Fraud

Fraud is a constant in our lives and must be recognized and eliminated wherever possible.In business, non profit, and business environments it is the responsibility of everyone within an organization to be able to identify fraud. If we do not perform due dilig ...

On-Demand Webinar

Work Has Been Suspended – What Damages Can A Contractor Recover

When an owner issues suspends work directive is the contractor entitled to recover delay and delay damages.? This session examines what damages are typically owed when work is suspended and some limitations of suspension damages. Five court cases setting forth ...

Recorded Webinar

Developing an Environmental Monitoring Program Satisfying FDA’s Listeria Monocytogenes Guidance

FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers. With few exceptions, this generally requires rigorous programs such as an Environme ...

Recorded Webinar

US FDA and EU MDR Basic Medical Device Documentation Requirements

This webinar will examine the requirements for the U.S. FDA's DHF -including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements. It will evaluate the documents' differing purposes / goa ...

On-Demand Webinar

Human Factors/ Usability Studies following ISO62366 and the New FDA Guidance

Human Factors/ Usability is the analysis of how people 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 ef ...