Mr.Charles H. Paul

In Good Manufacturing Practice (GMP) environments, human error is a persistent challenge that can lead to deviations, batch failures, regulatory non-compliance, and even product recalls. Studies show that over 70% of GMP deviations are attributed to human erro ...

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 ...

In the vast and intricate world of the life sciences industry, writing effective Standard Operating Procedures (SOPs) and work instructions emerges as a pivotal cornerstone. These well-crafted documents hold the power to unlock compliance with rigorous regulat ...

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 ...