Speaker Profile
CHARLES H. PAUL
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.

Charles H. Paul
May 08 2025
01 : 00 PM EST
90 Minutes
Effective Technical Writing for FDA Submissions
Technical Writing for FDA Submissions is a critical skill for professionals in regulated industries, including pharmaceuticals, medical devices, and biotechnology. Regulatory submissions to the U.S. Food and Drug Administration (FDA) must be clear, precise, and well-structured to ensure compliance and facilitate regulatory review. Poorly written submissions can lead to delays, requests for additional inform..

Charles H. Paul
June 05 2025
01 : 00 PM EST
90 Minutes
Writing Clinical Study Reports with clarity and Precision
Writing clinical study documents with clarity and precision is essential for ensuring accurate communication among regulatory agencies, clinical investigators, ethics committees, and other stakeholders. Clinical documents, such as study protocols, investigator brochures, and clinical study reports, serve as the foundation for regulatory submissions and decision-making. Any ambiguity or lack of precision can..

Charles H. Paul
July 10 2025
01 : 00 PM EST
90 Minutes
Streamlining Regulatory Documentation - Tools and Techniques
Regulatory documentation is a critical component of compliance in industries such as pharmaceuticals, medical devices, and biotechnology. However, the process of creating, managing, and maintaining regulatory documents is often complex, time-consuming, and prone to inefficiencies. Organizations must navigate evolving regulatory requirements from agencies like the FDA, EMA, and ISO while ensuring documentati..

Charles H. Paul
August 07 2025
01 : 00 PM EST
90 Minutes
Crafting clear and compliant SOPs for Pharmaceuticals and Medical Devices
Standard Operating Procedures (SOPs) are essential documents in the pharmaceutical and medical device industries, serving as the foundation for compliance, consistency, and operational efficiency. Regulatory bodies such as the FDA, EMA, and ISO 13485 require organizations to establish clear, well-documented procedures to ensure product quality, patient safety, and adherence to Good Manufacturing Practices (..