How to Avoid These Top 7 FDA Compliance Pitfalls

[fa icon="calendar'] Thu, Oct 13, 2016 / by Rachel Beavins Tracy

The number of warning letters sent by the U.S. Food and Drug Administration (FDA) jumped nearly 80 percent from 2007 to 2013, with life science companies contributing the most to this number.

Staying ahead of FDA compliance issues can be a difficult task, especially when you consider all the moving parts involved in the pharmaceutical and medical device manufacturing process.

In this post, we’ll take a look at the top FDA compliance pitfalls, with proven strategies on how you can avoid them.

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Life Sciences

4 Document Control Gaps That Can Cause Big Problems (and How to Avoid Them)

[fa icon="calendar'] Thu, Sep 29, 2016 / by Rachel Beavins Tracy

Document control is central to certification and regulatory requirements that include multiple ISO standards, U.S. Food and Drug Administration (FDA) regulations and Good Manufacturing Practices (GMP).

And yet, according to a McKinsey & Company report, employees spend almost 20% of their time searching for and gathering internal information. That means out of every 5 workers, only 4 are actually getting work done at any given moment.

The problem points to how common document control problems are in many organizations. In this post, we’ll examine 4 of the most common document control gaps and what you can do to fix them.

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Quality Management Life Sciences Document Control Food and Beverage aviation EHS

From Patient to Partner – How Today's Healthcare is all about the Consumer

[fa icon="calendar'] Wed, Sep 28, 2016 / by Alexandre Alain

With Patients New at the Center of the Consumer Healthcare Industry, Pharma is Pulling Out All the Stops to Make Sure Their Demands Are Met

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Life Sciences Healthcare

Steps You Can Take Now to Manage Recalls Better in the Future

[fa icon="calendar'] Tue, Sep 27, 2016 / by Rachel Beavins Tracy

Drug recalls by the U.S. Food and Drug Administration (FDA) have skyrocketed in recent years, reaching more than 9,000 recalls in 2015.

And while nobody likes to think about the possibility of a recall, having a plan ahead of time can mean the difference between a streamlined recall and widespread public scandal.

The steps discussed in this post can help set you up for a smooth recall process, even if you outsource recall management to an outside consulting firm.

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Life Sciences

7 Must-Haves for Supplier Quality Agreements

[fa icon="calendar'] Thu, Sep 08, 2016 / by Rachel Beavins Tracy

Supply chain failure is considered a top threat to life science companies, second only to intellectual property theft. Despite the risks, the market for contract manufacturers continues to grow at a rapid pace. In fact, experts predict the global contract manufacturing market for pharmaceuticals will exceed $79 billion in 2019.

There are several reasons for this rapid growth:

  • Contract manufacturing allows companies to increase capacity without the overhead of increasing their own staff and production capabilities. This lets companies move more drugs through the pipeline of FDA approvals faster.
  • For some startups with almost no manufacturing capability, it is the only route to manufacturing their products.
  • Suppliers and contract manufacturers can provide specialized expertise that helps expedite the drug development and manufacturing process.

To achieve these benefits while mitigating the risks, many companies turn to supplier quality agreements as a way to ensure compliance with internal and regulatory standards.

In this post, we’ll look at 7 must-haves for your supplier quality agreements. 

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Life Sciences

7 Top Tips for Complaint Management in the Life Sciences

[fa icon="calendar'] Wed, Aug 31, 2016 / by Alexandre Alain

Complaint Management is Key for Life Science Companies to Mitigate the Risks Posed by Social Media

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Complaint Handling Life Sciences

4 Hidden Dangers in Your Compliance Management Process

[fa icon="calendar'] Thu, Aug 18, 2016 / by Rachel Beavins Tracy

Compliance management is a top priority for companies in the pharmaceutical and medical device industries. You may think you have everything under control, but many companies don’t find out about the hidden dangers lurking in their process until it’s too late.

With this in mind, let’s take a look at the 4 biggest dangers hiding in your compliance management process, so you can take steps to address them before it’s too late.

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Life Sciences

6 Signs You Need FDA Compliance Software

[fa icon="calendar'] Thu, Aug 04, 2016 / by Rachel Beavins Tracy

The U.S. Food and Drug Administration (FDA) sent more than 17,000 warning letters in 2015, also recalling more than 9,000 products. While these enforcement activities may have been a wakeup call for some, others undoubtedly saw the writing on the wall for some time before the hammer came down.

To help you see where your company might be vulnerable, this post will discuss 6 of the biggest signs your company needs FDA Compliance Software

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Life Sciences

5 Processes Ripe for Automation in the Life Sciences

[fa icon="calendar'] Tue, Jul 19, 2016 / by Rachel Beavins Tracy

In any situation, you can have everything planned out to the “T” and still have unexpected problems. That’s because despite our best-laid plans, there are always factors outside our control.

Part of it is just entropy, or the universal tendency of things to move towards chaos (trying to keep a home tidy is a macro-scale example). But there’s another important driver of disorder that accounts for many stumbling blocks—the human element.

And while there will always be things only humans can do, there are many processes ripe for automation in the life sciences that can save time and money while reducing errors. Let’s look at 5 of them.

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Life Sciences

Bowtie, Risk Matrix or Decision Tree: Which Should You Use?

[fa icon="calendar'] Thu, Jul 14, 2016 / by Rachel Beavins Tracy

I’m the type of person who prefers my neighborhood hardware store over the big box home improvement places. Sure, there are fewer options, but that makes choosing easier. What’s more, the employees at my local store are infinitely more helpful, asking what I want and walking me directly to the tools I need.

Today’s post will help you better understand exactly the Risk Management tools you need for different situations. We’ll look at 3 essential risk models in your EHS or quality management toolkit: the bowtie, the risk matrix and the decision tree.

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Quality Management Life Sciences Food and Beverage aviation EHS Risk Management

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