Charles Paul
Charles Paul
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.
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3-Hour Virtual Seminar on 510(k) and PMA Submissions Process
The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its... -
Good Clinical Practices Review of ICH E6
The webinar will establish the foundation for this subject by defining GCP and discussing GCP in relation to its historical perspective. The thirteen core principles of GCP are essential to understanding how GCP is structured and expected to be... -
FDA Audit Best Practices – Do’s and Don’ts
The FDA has been increasing its surveillance of regulated industries. While it is a given that companies must meet their regulatory requirements, how company staff handle an audit and interact with FDA inspectors, can mean the difference between a... -
ISO 13485 – Medical Device Quality Management Systems
ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and... -
How FDA trains its Investigators to Review CAPA and How should you prepare
The most common finding during any FDA inspection deals with issues that impact, are the result of, or are centered in the organization’s CAPA system. Invariably, FDA inspectors will spend a great deal of their time when visiting your... -
3-Day Annual GMP Master Class for 2022 – Virtual Seminar
cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products. It is crucial, for any entity to be compliant,... -
3-Hour Virtual Seminar on Technical Training in Life Sciences
This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory... -
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,... -
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 – Key Strategies to implement proper Transition
The new EU In Vitro Diagnostics Regulation is not all that new or very different from the original 20-year old In Vitro Diagnostics Directive. That’s the good news. The bad news : there will be a significant amount of... -
Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
This webinar will provide the regulatory requirements (US) for complaint handling in the Medical Device and Pharmaceutical industries. The session will include requirements for complaint files and key requirements of: Complaint Procedures Investigations What to document when it is... -
CE Marking in the EU – Latest Regulations
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet... -
Line Clearance – Compliance Implications, Enforcement, and Best Practices
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. Preventing cross-contamination requires a precise accountable... -
6-Hour Virtual Seminar on GxP and the Quality System
GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good... -
US vs EU – Medical Devices Compliance and Regulatory Affairs
This webinar will provide an understanding of the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations.... -
3-Hour Virtual Seminar on Human Error Prevention in the Life Sciences
This 3-Hour virtual seminar 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... -
4-Hour Virtual Seminar on FDA Inspection Readiness – Be Ready!
Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill... -
FDA’s Medical Device De Novo Reclassification Process
The De Novo process is a complex process that has significant implications for the manufacturer of post-amendment devices in terms of how their devices are classified. In addition, the FDA has recently revised the regulations in 21 CFR part... -
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. It... -
4-Hour Virtual Seminar on Write SOP’s and Work Instructions that Really Work
This seminar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business and the functions comprising it. Writing Standard Operating Procedures and Work Instructions is technical... -
510(k) and PMA Refuse to Accept Policy
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,... -
Good Manufacturing Practices – 3 Hour Virtual Seminar
What are Good Manufacturing Practices? They are a set of practices that are required to comply with regulations and industry standards that insure that your products are effective as claimed and are pure and defect free. GMPs minimize the... -
ANDA Submission and GDUFA Final FDA Guidance
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA’s Center for Drug... -
Sale!
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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... -
FDA Establishment Inspections – What to Expect
The Food, Drug, and Cosmetic (FD&C) Act gives FDA the authority to conduct inspections at drug and medical device manufacturing facilities as well as other regulated industries. Those companies manufacturing drugs and higher risk medical devices, are prime candidates... -
Best Practices for Having Successful Performance Discussions
How we talk about performance – how successful we are in doing this – is critical to the team relationships we forge and the effectiveness of team performance. Part of talking about performance is knowing how to have an... -
4-Hour Virtual Seminar on Project Management for Non-Project Managers
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
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... -
ANDA Submission and GDUFA Final FDA Guidance
Just as everyone was beginning to get conversant with GDUFA’s confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying... -
Good Manufacturing Practices – 3 Hour Virtual Seminar
What are Good Manufacturing Practices? They are a set of practices that are required to comply with regulations and industry standards that insure that your products are effective as claimed and are pure and defect free. GMPs minimize the... -
Human Error Prevention in Pharmaceutical Manufacturing
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. Human... -
HACCP – Hazard Analysis and Critical Control Points
HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and... -
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is a process that allows a single audit to occur of a medical device manufacturer’s Quality Management System to determine if it satisfies the requirements of multiple regulatory jurisdictions. The MDSAP Audit... -
Risk Assessment for Medical Devices
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... -
Building a Compliant Documentation and Training System – 3 Hours Virtual Seminar
Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and... -
Avoiding 483’s Throughout your Organization – Strategies, Risk and Mitigating Approaches
Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual... -
Project Management for Non-Project Managers
It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of... -
Sale!
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New EU Medical Device Regulation – Everything That You Need To Know
In February of this year, the EU released the official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation. The current MDR stands at 350 pages and is a complex array of regulations written in... -
Building a Compliant Documentation and Training System – 3 Hours Virtual Seminar
Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and... -
Sale!
Project Management for Non-Project Managers – 3 Hours Virtual Seminar
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
Understanding Medical Device Design Controls
Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and... -
New EU Medical Device Regulation – Everything That You Need To Know
In February of this year, the EU released the official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation. The current MDR stands at 350 pages and is a complex array of regulations written in... -
Preventing Medical Device Recalls
This webinar will enable you to understand the classes of recalls and their relationship to deficiencies in the design and development process, how to develop a strategy for preventing recalls right from the beginning of the process and how... -
Sale!
Best Practices in Providing Coaching and Feedback to Team Members
Why Should You Attend Most times, we conform and accomplish satisfactory work because we are forced to by management, our peers, and the organization. Superior work on the other hand is only achievable when we want to achieve... -
Sale!
Building a Compliant Documentation and Training System
This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective... -
Sale!
Medical Device Classifications
When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process. The... -
FDA and EU Medical Device Submissions
The basic requirements for medical device regulatory submissions are essentially the same between the FDA and EU while the individual country and region requirements for submission are somewhat different. It is imperative to understand the similarities and differences when... -
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
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... -
Achieving Compliance Excellence through effective Training, Documentation and Management
This workshop will describe the environment in which success can be fostered with the tools that you already have at your fingertips – compliance documentation, training, and management structure. An effective model of human performance will be described and... -
Good Manufacturing Practices for Medical Devices
This training concerning Good Manufacturing Practices is a requirement for all staff involved in the manufacturer of medical devices. Regulations are complicated, and today more than ever before, because of global regulatory requirements, companies must be familiar with and... -
Medical Device Classifications
When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process. The... -
Working Effectively with Customers and Suppliers
Your success at your company – your ability to get things done efficiently and effectively – is dependent upon your ability to manage your key relationships within the organization. Those relationships take many forms. They include your relationships with:... -
Selecting the Most Economical and Effective Training Methods and Media
Training departments in the corporate setting today are increasingly required to do more with less. In this time of new and innovative but expensive training technology such as eLearning and 3D simulations, training directors often choose glitz and glamour... -
Working Effectively with Customers and Suppliers
Description: Your success at your company – your ability to get things done efficiently and effectively – is dependent upon your ability to manage your key relationships within the organization. Those relationships take many forms. They include your relationships... -
CAPA – Corrective Action Preventive Action
Description: How CAPA’s are executed and managed is crucial to maintaining a compliant organization. Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top five list for adverse observations. This course highlights the... -
Good Manufacturing Practices for Medical Devices
Description: This training concerning Good Manufacturing Practices is a requirement for all staff involved in the manufacturer of medical devices. Regulations are complicated, and today more than ever before, because of global regulatory requirements, companies must be familiar with... -
Achieving Compliance Excellence through effective Training, Documentation and Management
Description: This workshop will describe the environment in which success can be fostered with the tools that you already have at your fingertips – compliance documentation, training, and management structure. An effective model of human performance will be described... -
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
Description: 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... -
Conducting a Documentation and Training Analysis
Description: The secret to effective compliance documentation and technical training lies in how the analysis is conducted and how training and compliance documentation are developed as a result of that analysis. Many regulated industries have a multitude of documents... -
Line Clearance – Compliance Implications, Enforcement, and Best Practices
Description: 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. Preventing cross-contamination requires a precise... -
Combination Products – Applying the Appropriate Regulations
Description: Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and... -
HACCP – Hazard Analysis and Critical Control Points
Description: HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution... -
HACCP – Hazard Analysis and Critical Control Points
Description: HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution... -
Working Effectively with Customers and Suppliers
Description: Your success at your company – your ability to get things done efficiently and effectively – is dependent upon your ability to manage your key relationships within the organization. Those relationships take many forms. They include your relationships... -
CAPA – Corrective Action Preventive Action
Description: How CAPA’s are executed and managed is crucial to maintaining a compliant organization. Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top five list for adverse observations. This course highlights the... -
Good Manufacturing Practices for Medical Devices
Description: This training concerning Good Manufacturing Practices is a requirement for all staff involved in the manufacturer of medical devices. Regulations are complicated, and today more than ever before, because of global regulatory requirements, companies must be familiar with... -
Achieving Compliance Excellence through effective Training, Documentation and Management
Description: This workshop will describe the environment in which success can be fostered with the tools that you already have at your fingertips – compliance documentation, training, and management structure. An effective model of human performance will be described... -
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
Description: 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... -
Conducting a Documentation and Training Analysis
Description: The secret to effective compliance documentation and technical training lies in how the analysis is conducted and how training and compliance documentation are developed as a result of that analysis. Many regulated industries have a multitude of documents... -
Line Clearance – Compliance Implications, Enforcement, and Best Practices
Description: 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. Preventing cross-contamination requires a precise... -
Combination Products – Applying the Appropriate Regulations
Description: Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and...
