Miss.Meredith Crabtree

In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success. The Most Common FDA Observations and Prevention Strategies' training addresses the critical need for professi ...

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks. Participants will learn systematic approaches to identify root causes, develop effe ...

In today’s highly regulated pharmaceutical and medical device industries, maintaining robust Quality Management Systems (QMS) and ensuring data integrity are critical to compliance with FDA standards. With the increasing reliance on digital systems, including ...

In today's regulatory landscape, a strong quality culture is essential for preventing compliance issues and ensuring consistent product quality. Regulatory bodies, including the FDA, increasingly emphasize the need for organizations to establish and maintain a ...

"The FDA and Cosmetic Oversight - What does that look like?" is a training session aimed at providing participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating cosmetics. The training covers various aspects, includi ...

In today’s highly regulated pharmaceutical and medical device industries, maintaining robust Quality Management Systems (QMS) and ensuring data integrity are critical to compliance with FDA standards. With the increasing reliance on digital systems, including ...

Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...

The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...

The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...