Mr.Charles H. Paul

Effective technical writing is a cornerstone of successful FDA submissions, serving as a critical bridge between scientific data and regulatory review. Regulatory agencies like the FDA rely on clear, concise, and well-structured documentation to evaluate the s ...

In today's fast-paced and highly collaborative work environments, project management skills are indispensable, not only for designated project managers but for professionals across various roles and industries. Understanding the fundamentals of project managem ...

The U.S. Food and Drug Administration (FDA) is a federal agency tasked with protecting public health by ensuring the safety, efficacy, and quality of medical devices, drugs, and other healthcare products. Established in 1906, the FDA has evolved to become a gl ...

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 ...

Root Cause Analysis is a critical component of CAPA, aiming to identify the underlying causes or factors that contribute to problems or non-conformances. By analyzing these root causes, organizations can gain a comprehensive understanding of the issues they fa ...

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.  This training will work through the risk analysis process from risk identification, risk mitigation, risk communica ...

The subject of this webinar is building the project team.  The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team members’ ongoing commitment to the successful completion of the project ...

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages. Decomposing a task is not a trivial or intuitive process.  It is something that must be explained and p ...

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that ca ...

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.   Those processes include: Integrated change control Scope validation Scope control.  Schedule control ...