Charles H Paul
President, C. H. Paul Consulting, Inc.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, 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. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
Upcoming Webinar
Applying Global Standards to Life Sciences Compliance Documentation
The documentation required by regulation - to include standard operating procedures and work instructions - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement - as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to know how to write those documents to properly meet those needs. Of late, there has been global guidance on how those documents should fit into the hierarchy of documents and how they should be structured to meet regulatory requirements. This webinar will address all of these areas.
Live Session Tuesday, 17 December 2019, 10:00 AM PDT | 01:00 PM EDT, Duration: 60 Minutes

Recorded Webinar
FDA's Medical Device De Novo Reclassification Process
Today, any new medical device that is found not substantially equivalent for a reason other than performance data not previously classified based on risk is "automatically" or "statutorily" classified as a Class III device. This occurs because, by definition, a new device type would not be equivalent to a device type on the market before the 1976 Medical Device Amendments were placed in force or that has since been classified as a Class I or Class II device. This can have many levels of implication to a manufacturer of a low-risk device that suddenly finds themselves in the position of having their device classified as a Class III.
Recorded Session Get life time access for one participant with download option!

Writing Effective Standard Operating Procedures and 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 that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement - as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.
Recorded Session Get life time access for one participant with download option!

Understanding Combination Products: Navigating the Rules and Regulations
This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.
Recorded Session Get life time access for one participant with download option!

GMPs for Medical Marijuana Production Operations Cannabis GMP
Legal marijuana is one of the fastest-growing industries in the U.S., with more and more states starting to legalize medical marijuana to varying levels of control and regulation. However, the federal government has not yet legalized medical cannabis (though this situation might soon change). As a result, the industry lacks a common framework/standard for food safety - compared to other industries like pharmaceuticals and food. In such a scenario, companies that produce and sell marijuana products have a huge challenge ahead of them: how do they ensure that their products are safe - and how do they maintain their consumers' trust. Leaders in the cannabis industry are leading the way out of this confusion and opting for high safety and Good Manufacturing Practices (GMPs) - and so should you.
Recorded Session Get life time access for one participant with download option!

Preventing Human Error in the Life Sciences
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Recorded Session Get life time access for one participant with download option!

Leverage Regulatory Documentation: Write Sops That Actually Work and Have Value
Compliance documentation to include Standard Operating Procedures, 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 that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to know how to write those documents to properly meet those needs.
Recorded Session Get life time access for one participant with download option!

Project Management in the Life Sciences - Tips and Approaches
Project management is often called the accidental profession because there is no professional path from specific university education to actual practice. It is rather, a body of skills that many managers assume that most people possess. That is simply not the case. Furthermore, the types of projects that this webinar addresses, projects addressed by internal work teams, are often led by those within the organization with the least experience to do so. This webinar will help that manager get started and placed on the right track.
Recorded Session Get life time access for one participant with download option!

Classifying Medical Devices, The De Novo Process and the FDA's Final Rule to Simplify Medical Device Classification Procedures
This webinar will review the Medical Device Classification Procedures which includes the De Novo process in conjunction with the recent changes to 21 CFR 860 that pertain to the reclassification of the post amendment devices and the De Novo process in general.
Recorded Session Get life time access for one participant with download option!

GMP's for Medical Marijuana - Insight into Manufacturing, Labeling, Tracking and Disposal requirements
Legal marijuana is one of the fastest-growing industries in the U.S, with more and more states starting to legalize medical marijuana to varying levels of control and regulation. However, the federal government has not yet legalized medical cannabis (though this situation might soon change). As a result, the industry lacks a common framework/standard for food safety - compared to other industries like pharmaceuticals and food. In such a scenario, companies that produce and sell marijuana products have a huge challenge ahead of them: how do they ensure that their products are safe - and how do they maintain their consumers' trust. Leaders in the cannabis industry are leading the way out of this confusion and opting for high safety and Good Manufacturing Practices (GMPs) - and so should you.
Recorded Session Get life time access for one participant with download option!

Understanding the FDA's Revised Medical Device Product Guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) - Traditional, Abbreviated, and Special.
Recorded Session Get life time access for one participant with download option!

Understanding Combination Products: Navigating the Rules and Regulations
This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.
Recorded Session Get life time access for one participant with download option!

Classifying Medical Devices - US and EU
This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for the EU.
Recorded Session Get life time access for one participant with download option!

Training in Regulated Environments: Is "Read and Understand" Sufficient?
This webinar will explain the best-in-class applications of training and how training can significantly contribute to not only world-class compliance but improved operational performance, improved quality, and improved employee/associate safety.
Recorded Session Get life time access for one participant with download option!

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