Alexa Sussman

Alexa Sussman

Recent Posts

6 FDA-Recommended Considerations for Smart and Safe Medical Device Interactions

[fa icon="calendar'] Wed, Nov 29, 2017 / by Alexa Sussman

In September 2017, the FDA announced a guidance called “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance will help Life Science organizations via considerations for design and development of medical devices to safely exchange information.

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Life Sciences

Thoughts from the EtQ Family: What We’re Thankful For

[fa icon="calendar'] Wed, Nov 22, 2017 / by Alexa Sussman

It’s that time of year again—time to celebrate family, friends and food. But most importantly, it’s time to reflect on what you’re thankful for. We did that here at EtQ, and thought we’d share some responses from our team.

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Life at EtQ

How to Turn Challenges into Opportunities with a Quality Management System (QMS)

[fa icon="calendar'] Fri, Nov 17, 2017 / by Alexa Sussman

Everyone faces challenges, personally and with their businesses. People say the true mark of character is how you respond to challenges, and that goes for your business too.

When faced with challenges you have two options: become a victim of circumstance or use the tools around you to turn them into an opportunity. With a Quality Management System (QMS), you can easily turn many operational challenges into opportunities for success.

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Quality Management

The Samurai Approach to Quality Management

[fa icon="calendar'] Thu, Nov 02, 2017 / by Alexa Sussman

Samurai warriors are symbols of discipline and nobility. But they didn’t just get there overnight—they dedicated their lives to training and learning.

Two main ideas that Samurais reflect are training hard and preparing for the worst. That way, they are calm, cool and collected when attacked and can rely on their strong skillset to help them succeed.

Your quality management approach shouldn’t be all that different. Preparing like a Samurai could help your organization better handle the battle of adverse quality events.

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Quality Management

Costume Ideas for Your Quality Themed Halloween Party

[fa icon="calendar'] Tue, Oct 31, 2017 / by Alexa Sussman

Scrambling to find a last-minute costume for your quality themed Halloween party? Don’t worry, we’ve got a few ideas for you.

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Quality Management

What Can BP Do to Improve its Safety Culture?

[fa icon="calendar'] Wed, Oct 25, 2017 / by Alexa Sussman

Almost 30 accidents occurred this year at BP’s operations site in Alaska. Of those incidents, five were considered “Tier 1 events,” which put the lives of employees at risk.

“We must change now,” said BP Alaska President Janet Weiss. “We must have a reset.”

The change she’s referring to is a change in safety culture. Out of date safety processes and a disengaged safety culture are causing these incidents that, if continue, will result in death or irreparable damage.

So what can BP—and companies in similar positions—do to overhaul their safety culture and make permanent changes?

Here are three aspects of EHS management to utilize to promote an improved safety culture.

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Best Practices for Prioritizing Pharmaceutical Serialization

[fa icon="calendar'] Tue, Oct 10, 2017 / by Alexa Sussman

The 2013 Drug Supply Chain Security Act (DSCSA) is full swing in its implementation phase. This act hopes to drastically reduce—or even eliminate—counterfeit, altered or incorrect drugs in the pharmaceutical market.

Some requirements under this act include providing electronically formatted transaction data to trading partners, timeframes on replying to verification requests, verifying product identifiers of suspect and returned items and quarantining suspect products and clearing or disposing of them. But the most impactful change is the requirement of product serialization.

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Life Sciences

What Life Science Companies Can Learn from Former Equifax CEO Richard Smith

[fa icon="calendar'] Wed, Oct 04, 2017 / by Alexa Sussman

On Tuesday, former Equifax CEO Richard Smith testified before the House Energy and Commerce Committee about the credit firm’s recent massive security breach.

Although Smith took full responsibility for the breach occurring under his leadership, congress was unsatisfied with his apologies and criticized his lack of actions immediately following the incident.

“It’s like the guards at Fort Knox forgot to lock the doors and failed to notice thieves emptying the vaults,” said Greg Walden, the Republican chairman of the House subcommittee.

This issue brings to light the very real threats to cybersecurity—and Life Science organizations should take heed.

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Life Sciences

A Look into Artificial Intelligence in Medical Devices

[fa icon="calendar'] Mon, Sep 25, 2017 / by Alexa Sussman

Sharing a name with one of the most popular Artificial Intelligence (AI) technologies of current times (thanks for that, Amazon), I’ve learned a thing or two about what AI is capable of. Beyond summoning your road trip playlist or helping your figure out what actor was in that movie you watched last week, AI is capable of more than you could imagine.

The medical device industry has noticed this too—and they’re using it to save lives.

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Life Sciences

New Video: A Quality Management Platform for Businesses of Every Size

[fa icon="calendar'] Wed, Sep 20, 2017 / by Alexa Sussman

Humans are a progressive species, always looking to innovate and move forward. But with progress comes change, and change brings new risks.

That’s where EtQ comes in. For over 25 years, we’ve been the constant support businesses need to move forward. We’re with you every step of the way, growing and scaling as your business adapts in a fast-paced environment.

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Quality Management Life Sciences Food and Beverage EHS

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