Miss.Meredith Crabtree

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 ...

In regulated industries, managing changes to processes, equipment, or materials is critical to ensuring compliance and maintaining product quality. Effective change control systems not only help organizations avoid compliance issues but also streamline operati ...

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 ...

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 ...

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 ...