Unlocking the Value of Complaints
Complaint handling in the medical device industry entails more than appeasing unhappy customers. Itâ...
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Discussing the Real Problem: 5 Why Method for a Root Cause Analysis
Over the years, we’ve discovered that the majority of repetitive or frequently occurring issue...
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Ask the Experts: Designing a Quality System that Works!
The Quality System, or Quality Management System (QMS) is not only a standard to aspire to, but also...
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How to Write Compliance Responses to the FDA that Builds Trust
This Advanced Compliance Writing Webinar will teach you how to draft responses to enforcement action...
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Supply Chain Quality Management
Overcome supply chain challenges faced by manufacturers.
Outsourcing goods and services can be effic...
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Leverage Complaints Insights into better Quality, Compliance and Customer Satisfaction
Complaints! Although we may be focused on quality, any product we sell, service we provide, or even ...
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Design Quality: Connecting Design to Documentation
Align your Design Processes with your Quality System Processes to achieve a faster time to market an...
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Implementation Tips for EU IVDR: Evaluate your Preparedness
Are you ready for the new EU IVDR regulations to go into effect on May 26th?
From 26th May 2022, IVD...
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Supply Chain Innovation Today: The Imperative of Future-Proofing – benchmark study
As much as 65% of the value of a company’s products or services is derived from its suppliers and ...
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Making the Digital Quality Journey in Cell and Gene Therapy: From Bench to Bedside to Benefit
Cell and gene therapies (CGTs) are the next wave of therapeutic innovation in the life sciences indu...
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Access Granted: Discussion on Implementing a Permit to Work Program
How comfortable are you with seeking support from stakeholders for a new program? Have you been able...
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Transforming Quality in the Cloud
Many Life-Science organizations still suffer from DRIP (data rich, information poor) because of on-p...
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The Risk Based Approach to Advanced Therapies Manufacturing
The use of living cells and tissues (or blood derivatives) as raw material in the manufacturing proc...
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FDA’s Emergency Use Authorization is Coming to an End. Are you Ready?
Time is running out! The Emergency Use Authorization time is ending and if you don’t act quickly y...
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Speed of Digital Health: Opportunities and Challenges in Software as a Medical Device (SaMD)
Digital health has the potential to make the delivery of healthcare more accessible, convenient and ...
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Digital Twins – The Big Opportunity for EHSQ
The digital twin market is expanding as firms turn to IoT sensors, data analytics and modelling to f...
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Future-Proof Manufacturing – A Live Roundtable Discussion
As uncertainty continues into 2022, practical experience shared by industry leaders is a vital sourc...
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Management Review Meeting – Beyond meeting and minutes!
To most companies, a management review meeting (MRM) is just a formality to discuss and record the m...
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How a Safety Control Tower can Protect your Organization
Getting to the bottom of the safety data story can mean the difference between deploying a highly ta...
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Future Proofing Growth and Customer Satisfaction at Burlington Medical
When the Covid-19 crisis hit, many medical device manufacturers were unprepared for the impacts and ...
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How Good Writing can Prevent Painful Regulatory Consequences
Don’t let documents compromise your organization
Effective Compliance Writing is key to positive...
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Effective Management Reviews for Quality & Safety
Does management review feel like it’s just a checkbox requirement for your quality or safety syste...
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The Importance of a Permit to Work System
Regulations and safety practices have evolved to improve the safety standards inside an organization...
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Getting to the Root of the Problem (Using 5 Why)
Understanding root cause analysis and correcting and preventing problems from recurring is the core ...
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Supplier Communication – Keys to Successful Partnerships
They say communication is the key to any good relationship. Today, we communicate through email, let...
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Tips for a Better Investigation and Root Cause: Going Deeper than Human Error
The process of incident investigations is a common practice that all safety professionals are experi...
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Exposing Data Across Your Company to Drive Efficiencies and Quality
The reality of the Global Pandemic has changed the way we work, way we interact, way we do business,...
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Medical Device Advertising and Promotion in the Internet World
New avenues for internet marketing raise unique questions not explicitly covered by existing FDA reg...
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Supply Chain Issues / Collaboration – A Manufacturing Spotlight Series Webinar
Today’s supply chains are complex, and manufacturers rely on them to get the raw materials and...
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Keep the Heart of QMS Robust: Master How to Ensure Effective Corrective Action in the CAPA Process
As an organization grows, there is an increase in complexity of its operation. Complexity blurs a cl...
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