All articles from Kelly Stanton

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient

What is an ICH Q10 pharmaceutical quality system?

What is a quality management system (QMS)?

Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

Everything you need to know about ISO 13485

Qualio launches new validation approach

9 core elements of a quality management system [Examples]

The ultimate guide to change control for life sciences companies

What is a bill of materials? A guide for medical devices

Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11: A guide for clinical trial compliance

What is an electronic batch record?

The pros & cons of pharmaceutical contract manufacturing

A complete guide to 21 CFR Part 11 for medical device manufacturers

Biotech vs pharma: Differences and similarities

The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies

Tips for moving from a paper-based QMS to an eQMS

4 Things Pharmaceutical Startups Need for Document Management

The Risks of ISO 9001 Nonconformance

Identifying the 4 Most Common Problems With Your CAPA Process

5 Major Total Quality Management Principles for Medical Device Startups

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

The 13 Essentials of a Quality Plan for Medical Device Companies

3 Important FDA Medical Device Guidance Documents to Bookmark

The Top 3 Pharmaceutical Venture Capital Firms

What is the ISO 13485 Quality Manual?

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

What is the FDA 21 CFR? Requirements Overview

4 Major Class II Medical Device Requirements

How to Build a Document Control Procedures Manual

5 Amazing Medical Device Document Management Tips

How to Master Pharmaceutical QA in 4 Simple Steps

Qualio is Officially ISO 9001 Certified!

What to Look for in Quality Management Consulting Services? [4 Factors]

What Are The 4 Phases of Clinical Trials? (And How to Guarantee Quality Assurance During Every Step)