Miss.Meredith Crabtree

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 ...

"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 ...

The FDA and Dietary Supplement Oversight - What does that mean?" is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements. The training ai ...

In FDA-regulated industries, quality agreements are vital tools for ensuring that manufacturers and their suppliers or contract organizations are aligned on quality and compliance expectations. These agreements help define the responsibilities of each party an ...

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 most other regulatory agencies require formal written procedures. Your SOPs are likely the first thing an FDA investigator will ask for when they arrive at your facility.  Did you know that SOP deficiencies are one of the top 5 findings in FDA audi ...

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 ...

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 ...

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 ...

Attending this training will help the participants understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.  By learning how to write SOPs that satisfy FDA ...