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Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, 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.
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 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 ...
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 ...
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 ...
Agile project management has revolutionized industries worldwide by introducing a flexible, iterative approach to delivering high-quality products and services. Originating in software development, Agile methodologies emphasize collaboration, adaptability, and ...
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 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 ...
Human error remains one of the most significant challenges in medical device manufacturing, where precision and compliance are paramount. Mistakes during production or quality assurance can compromise product integrity, lead to costly recalls, and jeopardize p ...
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 ...