Mr.Charles H. Paul

Area Of Expertise : Medical Devices
20 Years Of Experience
Training Industry : Life Sciences

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

9 results Found
Live Webinar

Project Management for Non-Project managers

Today more than ever before the job titles that we hold are not entirely reflective of the work that we do.  Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex project ...

  • Basic
  • 90 Mins
  • Jul 06, 2022
Live Webinar

How to comply with the FDA’s Quality System Regulation 21CFR Part 820

21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, in ...

  • Basic & Intermediate
  • 60 Mins
  • Jul 12, 2022
On-Demand 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 ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

Understanding the EU Medical Device Regulation

The official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation have been released. The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese. There are many changes that anyone d ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Writing World Class Compliance documentation – SOPs & Work Instructions

Standard Operating Procedures and Work Instructions – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Risk management in medical device design and development

Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Introduction to FDA & EU Medical Device Submissions

More than ever before, medical devices are playing an increasing role in the healthcare of individuals across the world. Some medical devices pose little or no risk to patients while others can be life-sustaining. Medical devices utilize a variety of technologies to ...

  • Basic & Intermediate
  • 90 Mins
On-Demand Webinar

Medical Device 510K Submissions

There are three types of 510(k) submissions that can be submitted – Traditional, Special, and Abbreviated. The 510(k) process is considerably more rigorous than it once was, because of the following : Several international standards recognized by the FDA ...

  • Basic
  • 60 Mins
Recorded Webinar

Classifying Medical Devices Made Easy

This workshop will provide insight into the classification process as regulated by the FDA and will provide a methodology to assist in properly making your classifications. This workshop will cover the steps for classifying a medical device using the FDA Product Clas ...

  • 60 Mins