Feb 27, 2014

Quality Event Management: Free Recorded Webinar Shows How a Closed-loop Methodology Can Improve CAPA Systems

By James Jardine, Marketing Communications, MasterControl Inc.

Free Recorded Webinar Shows How a Closed-loop Methodology Can Improve CAPA SystemsQuality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!

The opening section of the first webinar features Peterson discussing the handling of quality events—how to take an occurrence (such as a customer complaint, a nonconformance, an audit finding, etc.) and determine the most efficient way to resolve the issue.

Feb 25, 2014

What Does the New FDA Guidance on Electronic Submissions Mean?

By Cindy Fazzi, Marketing Communications, MasterControl Inc.

Two years after the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, the FDA has taken a step forward in requiring electronic submissions under FDASIA. Do you know how this new requirement is going to affect your submissions?
The FDA released a draft guidance  in early February to address which submissions must be submitted electronically, which submissions are exempted, which ones can be waivered, and when this new requirement will take effect.
Under the new guidance, the agency will require the following to be submitted electronically: certain INDs, NDAs, ANDAs, and certain BLAs. The requirement will take effect “no earlier than 24 months” after the FDA issues a final guidance. The other areas (exemptions, waiver) are not as clear and the agency still has to work on the details.

Feb 19, 2014

Beyond Writing It Down

David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

By David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

“If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.  But what isn’t always so apparent is:

1. What should be written down?
2. Is there a special way to do it?
3. What are some of the common pitfalls to avoid? 
4. What happens when I make a mistake?

This article will attempt to answer those four questions.

Vendor-Created End-User Training: A Lifeline or Just Enough Rope to Hang?

 Donna Bailey, Instructional Design Specialist, MasterControl Inc.

By Donna Bailey, Instructional Design Specialist, MasterControl Inc. 

So you’ve implemented a new software system, and you’re supposed to go live with it in four weeks. It has taken you months to get to where you are: months bordering on a year. You’ve had to let some of your normal job responsibilities slide because of how much time this implementation is taking, but it can’t be much longer, right? You go through your checklist: Is the system configured the way you need it to be for your company? Check; or at least you think so. Are your documents imported and easy to find? Check; well, you can find them, but you honestly don’t know how your end users will find them. Do you have a support group at both your company and the software provider on the ready? Check; kind of. The people in your group went through the same training as you did so that means they know at least as much as you do, and you have a business card from the software trainer and the number for tech support if something goes wrong. Have you developed and distributed the end-user training? Hmmmm, no. Well, that can’t be too hard, right? Just take a couple of screenshots, write some steps, and bang—you have end-user training.

Feb 18, 2014

Medical Device Clinical Trials – How Do They Compare with Drug Trials?

Brandy Chittester, Director of Clinical Monitoring Services, IMARC Research, Inc.

By Brandy Chittester, Director of Clinical Monitoring Services, IMARC Research, Inc.

It seems like the clinical research world is often thought of in terms of pharmaceuticals.  Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.”  Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out.  And in some cases, for medical devices, clinical trials may not even be required! 

Feb 14, 2014

Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

by Lisa Weeks, Marketing Communications, MasterControl Inc.

Clocks ticking
The clock starts ticking the minute you receive your 483.
Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

How to Word Your Response Letter

Crafting a timely yet strong response letter to a 483 is both a science and an art. Knowing how to provide the answers the FDA and other regulators seek will help you avoid a warning letter or further notifications. Your response must be worded in a way that is acceptable to regulators. 

Feb 12, 2014

“3 Loops in 1” as Reflected in FDA Warning Letters

Cindy Fazzi

by Cindy Fazzi, Marketing Communications, MasterControl Inc. 

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process.  What is it and why is it critical?

“Three loops in one” is meant to help the quality team and other CAPA professionals come up with the right solution that resolves the issue in a compliant way, according to Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team (2).

3 Loops in 1
In a recent CAPA webinar, Peterson explained the “three loops in one” CAPA methodology. Let’s take a look at the different loops as explained by Peterson. I’m using examples of warning letters to demonstrate how they relate to the loops.

Feb 10, 2014

Collaboration is More Than Just a Buzzword in Regulated Environments

Marty Jackson, Professional Services Consultant, MasterControl Inc.

by Marty Jackson, Professional Services Consultant, MasterControl Inc.

Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”
Indeed Merriam Webster offers this definition: “to work jointly with others or together especially in an intellectual endeavor.”
In regulated environments, compliance affects an entire organization, making collaboration critical (1). The approval of a new drug or medical device, for example, requires concerted effort by all departments involved in a product lifecycle.    
For regulated companies, collaboration refers to a process that encompasses a lot of things. It could mean a quick document approval, or providing vital input on a document’s content, or a simple “thumbs up” or “thumbs down.”   
Providing an ample opportunity for teams to collaborate can make a great deal of difference in the process. When the right people are offered an opportunity to share their ideas, redline a document, and provide comments, the impact can be substantial.

Feb 5, 2014

MasterControl's Murray & Knauer Guest Speakers at MD&M West

MD&M Westby Robyn Barnes, Public Relations, MasterControl Inc.

If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week.  MD&M West is the world’s largest medical OEM event. 

This is an annual trek for MasterControl.  This year, you can visit the MasterControl crew in Booth 1962.  Stop by to visit with Jeff Haskell, Dave Stephens, and Paul Sanderson.  If you sign up in advance for a brief qualitymanagement system (QMS) demo, they’ll give you a gourmet coffee card. If you are pressed for time during the day, stop by the booth Wednesday February 12 from 3:30 – 5:00 PM for a cocktail reception. Jeff, Dave and Paul will all be there to greet you and answer questions about MasterControl’s QMS.