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Speaker Profile
MEREDITH CRABTREE

Meredith Crabtree has over 25 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith currently works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems


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$199.00
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

 Meredith Crabtree
 December 13 2023
 01 : 00 PM EST    
 90 Minutes
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

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 Quality System Regulations (QSR) with ISO 13485. This training will provide an overview of this proposal, highlighting its significance, potential be..

$199.00
SOPs- How to Write Them to Satisfy Those Inspectors

 Meredith Crabtree
 January 11 2024
 01 : 00 PM EST    
 75 Minutes
SOPs- How to Write Them to Satisfy Those Inspectors

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 audits? These deficiencies can compromise or cause failures in an organization’s entire Quality Management System, often leading to other FDA observations,..

$199.00
The FDA and Dietary Supplement Oversight- What does this mean?

 Meredith Crabtree
 February 02 2024
 01 : 00 PM EST    
 90 Minutes
The FDA and Dietary Supplement Oversight- What does this mean?

The topic of "The US FDA and Dietary Supplement Oversight" delves into the critical role played by the U.S. Food and Drug Administration (FDA) in regulating dietary supplements, aiming to ensure consumer safety and promote transparency within the industry. This comprehensive training provides a deep understanding of the FDA's oversight responsibilities, the challenges encountered in regulating dietary suppl..

Showing 1 to 5 of 5 (1 Pages)
$200.00
5 Key Components of Good Manufacturing Practices to obtain cGMP certification

 Meredith Crabtree
 Recorded Webinar
 60 Minutes
5 Key Components of Good Manufacturing Practices to obtain cGMP certification

Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..

$200.00
FDA/ ICH Guideline Q9 (R1) on Quality Risk Management

 Meredith Crabtree
 Recorded Webinar
 90 Minutes
FDA/ ICH Guideline Q9 (R1) on Quality Risk Management

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 of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential..

Showing 1 to 5 of 5 (1 Pages)