Quality management resources

Best practice guides, webinars, product info and podcasts.
Created by and for life science quality professionals.

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Topic
Media
Podcast

Insights from Biotech Investor and Pioneer Ron Shigeta

  Ron Shigeta is a serial entrepreneur & startup biotech pioneer. He’s also been a serial founder having run startups in AI drug tox detection ...
Guide
Regulatory

How to Prepare ISO 9001 Certification

Your life science company isn't required to secure ISO 9001 Certification. However, doing so will benefit your organization in a number of ways. ...
Webinar
Medical Device

Reducing Time & Cost to Market for Medical Devices

Developing and launching a product is never a linear process, and the medical device pathway to market can entail numerous complexities. In this ...
Podcast

Curing Incurable Diseases with Jeff Galvin from American Gene Technologies

  Subscribe on any major podcast player. What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're ...
Webinar
Medical Device

Product Webinar — Introducing Qualio Design Controls

Join Qualio's Product Team on September 1st at 1pm EDT / 10am PDT for a walkthrough of our new product: Design Controls. Design Controls is ...
Podcast

Improving Patient Safety at The Point of Care

  Subscribe on any major podcast player. Did you know about $6 billion is spent each year in medical device recall management? Having a product ...
Webinar
eQMS

The Quality Culture Playbook: How to Build a Quality Culture

To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the ...
Guide
Medical Device

How to Prepare ISO 13485 Certification

Has your life sciences company spent countless hours preparing for ISO 13485 Certification? Don't worry – you're not alone. Let us help you prepare ...
Podcast

Bringing New Tech to Developing Countries and Playing Pro Basketball

  Subscribe on any major podcast player. Today we welcome Mr. Assaf Barnea to the show. He is a former pro basketball player in Europe and currently ...
Podcast

How to Maintain a Quality Culture during Explosive Growth

  Subscribe on any major podcast player. Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in ...
Webinar
Pharmaceutical

Integrating Data Integrity Requirements

The biotech industry is moving at a rapid pace and digitally transforming. The bar is constantly rising with increased Compliance requirements. This ...
Guide
Pharmaceutical

The Perfect Quality Assurance Plan for Pharmaceutical Companies

In this guide, you'll learn how to create a perfect quality assurance plan for your pharmaceutical organization which safeguards your company from ...
Podcast

Using AI to Improve Healthcare Outcomes and Access with Sam Dribin

  Subscribe on any major podcast player. Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support ...
Podcast

Empowering Women With Personal Fertility Knowledge

  Subscribe on any major podcast player. Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to ...
Podcast

Fundraising Fundamentals with Greg Yap and JP Sanday from Menlo Ventures

  Subscribe on any major podcast player. Today’s guests are Greg Yap and Jean-Paul (JP) Sanday from Menlo Ventures where fundraising is the #1 ...
Podcast

Unlocking funding with IP and the inspiring story behind HAI Solutions

  Subscribe on any major podcast player. The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start ...
Podcast

Reducing Time to Market for Pharma Companies with Rapid Payer Response

  Subscribe on any major podcast player. Typically, it takes several months for third-parties and consultants in the life sciences industry to get ...
Guide
Regulatory

5 Considerations for Responding to an FDA 483 Letter

In this guide, we show you how to respond quickly and effectively to a 483 letter and get back to developing products. The FDA does not want to ...
Podcast

Spearheading the Life Science Industry with Claire Bonaci of Microsoft

  Subscribe on any major podcast player. Listen to this chat between Qualio CEO, Robert Fenton and Claire Bonaci from Microsoft about how the life ...
Podcast

Reducing Patient and Nurse Injuries with Charleen Solomon of AriseQ2

  Subscribe on any major podcast player. Did you know nurses are required to turn and change bed-bound patients every two hours? The primary reason ...
Product Info
eQMS

Integrations datasheet

Download our datasheet to learn how Qualio's integrations functionality: Connects your QMS to your other business-critical systems Breaks down ...
Podcast
Medical Device

Tips for Hardware & Software Med Device Product Development

  Subscribe on any major podcast player. Today’s guest is Rob Crowder, Head of Product at Nutromics in Australia, which has a booming life science ...
Podcast

Global Opportunities from Starting a Med Device Company in a Pandemic

  Subscribe on all major podcast players: Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth ...
Guide
Medical Device

9 Ways to Improve Quality in Medical Device Product Development

Ensuring compliance with regulatory standards and requirements is a top priority for every medical device manufacturer. Unfortunately, many ...
Guide
eQMS

Why your life science business needs electronic document management

Download our document management whitepaper to learn: Why more and more life science companies are embracing electronic document management How an ...
Podcast

Defining Quality: The Role, Responsibilities, and Industry

  Subscribe on any major podcast player. Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into ...
Product Info
eQMS

Document management datasheet

Download our document management datasheet to learn how Qualio: Empowers your organization with a centralized digital repository of quality ...
Product Info
eQMS

Training management datasheet

Download our training management datasheet to learn how Qualio: Provides a robust and holistic training environment for life science companies Embeds ...
Podcast

Treating Previously Undruggable Diseases: Dr. Ian Taylor at Arvinas

  Subscribe on any major podcast player. Most likely everyone reading this has been affected by cancer or knows someone who has had cancer. Using ...
Podcast

How to Maintain and Improve Quality Management While Working Remotely

  Subscribe on any major podcast player. Today on the podcast we're introducing a new type of episode: Quality Quick Tips.  Periodically we'll focus ...
Guide
Medical Device

Audit Readiness Checklist for Medical Device Companies

You know you want to be ready for the next audit, but how do you prepare? Use this complete checklist to evaluate your medical device company’s audit ...
Podcast
eQMS

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year. At the same time, businesses that weren’t deemed essential were ...
Podcast

How to Get Non-Dilutive Funding via Federal Agencies

Subscribe on any major podcast player. Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part ...
Podcast

Lessons from Building an Open Source Quality Community with Gill Berry

  Subscribe on any major podcast player. Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded ...
Product Info
eQMS

Design controls management datasheet

Download our design controls management datasheet to learn how Qualio: Gives your business a concerted, compliant and accelerated route to market for ...
Guide
eQMS

Audit Readiness Checklist

When it comes to preparing for your next audit, you want to check all the boxes. Use this comprehensive checklist to evaluate your organization’s ...
Podcast

Combating COVID-19 with the Open Source Volunteers Extended Project

  When the coronavirus pandemic began surging in February 2020, volunteers around the world sprang into action to do whatever they could to help.  As ...
Podcast
Medical Device

Expanding Med Device Distribution Internationally and in China

Subscribe on any major podcast player. Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...
Webinar
eQMS

Preparing for and Passing an Audit — Expert Panel

For quality teams in life science organizations, implementing the best ways to prepare for and pass internal and external audits can be challenging. ...
Webinar
Regulatory

Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements

Combination products represent a noteworthy prospect for the user with regular and long-term dosing requirements. The availability of commercialized ...
Guide
eQMS

12 questions to ask before you buy an eQMS

Access our guide to learn:   The 12 specific and detailed questions you should be asking eQMS vendors on your system hunt How to pinpoint the right ...
Podcast

Quality Management Fundamentals in Aerospace and Life Sciences

  Subscribe on any major podcast player. Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, ...
Podcast

Awakening Millions with Brain-Controlled Interfaces with Andreas Forsland, CEO of Cognixion

  Subscribe on any major podcast player. Imagine if Stephen Hawking couldn't communicate. The world's understanding of theoretical physics would be ...
Podcast
Biotech

Advancing Human Health with Turnkey Biotech Incubator Brazen Bio

  Subscribe on any major podcast player. Have you ever wondered why so many new biotech companies don't survive the first valley of death, which is ...
Webinar
eQMS

Tips for Maintaining and Improving Your QMS When Working Remote

Quality teams at pharma, medtech, and biotech companies can maintain and even improve their QMS while working remotely (unless you are working with a ...
Podcast

Rapidly Discovering and Extracting Natural Pharmaceuticals

  Subscribe on any major podcast player. Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform ...
Podcast

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

  Subscribe on any major podcast player. Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...
Guide

How to Build a Quality Culture

Quality is the cornerstone of every successful biotech, medical device, pharma, and life sciences organization. If your goal is bringing safe, ...
Podcast

Funding and Scaling your Med Device Startup with Jen Baird

  Subscribe on any major podcast player. Getting funding and scaling a medical device business alone is challenging. But challenges don't deter ...
Podcast

4x Cancer Survivor to CEO/Founder. Patient-led Innovation

  Subscribe on all major podcast players: What if the next time you went to the receive healthcare at a clinic or hospital, you came out with an idea ...
Webinar
eQMS

What is needed for ISO and FDA regulation in a Quality Management System

When considering how to setup your Quality Management System (QMS), it is first important to understand what is needed under ISO and FDA regulation ...
Guide
eQMS

How to evolve to a paperless eQMS

Access our guide to learn: The 3-step migration journey from paper to an electronic quality management system (eQMS) Top tips and recommendations for ...
Podcast

Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

  Subscribe on any major podcast player. Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell ...
Product Info
eQMS

Quality event management datasheet

Download our quality event management datasheet to learn how Qualio: Unlocks end-to-end control and visibility of all your quality events Drives ...
Podcast

Succeeding in Quality Consulting with Lisa Helmonds, VP of Operations at MWA Consulting

  Subscribe on any major podcast player. Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which ...
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