Why US?

 

     Our clients love us because we get results quickly and without drama.  When you’re in a regulatory squeeze, you require fast, professional, and precise advice so you can move on with running your business.

                   That’s exactly what we do!

     Because we aren’t a giant firm, we are nimble and react to our client’s “emergencies” and challenges fast. With our “First Responder” service, we will be in your office anywhere in the world in 24 hours if necessary.              

The MBCA First Responder service gives our clients  

great peace of mine. Our service minimizes outside    

interruptions from government regulatory agencies so

you may operate your business efficiently.

Learn about our First Responder Program

     Also, because we aren’t a giant company, our consultants are not receiving “on the job training” which you pay for in your fees.  Our team of consultants are all industry veterans with a reputation for getting results.

     Our “About Us” section tells more about who we are.  In short, MBC & Affiliates has been helping clients with compliance issues for 13 years.  Our CEO and Chief Consultant, Melita Ball, has served the industry for three decades.

 

                                    Our Process


1) 30 to 60-minute Complimentary Consult
We start with a complimentary consultation which is really a conversation. We want to thoroughly understand your needs and expectations.


• Did you receive a warning letter?
• Do you require training for your internal auditing staff?
• Are you facing an audit and wish to be prepared in advance?
• Do you wish help in verifying the compliance of your suppliers?


2) Detailed Proposal
After our initial conversation, we prepare a detailed proposal addressing the issues disclosed and discussed in the Complimentary Consultation process.


3) Assessment

When we are addressing compliance issues, we plan a 3 to 5-day (or longer for more complex issues) assessment to determine next steps.


4) Analyze Results
We analyze the results from our assessment.


5) Craft Detailed Plan
From the information obtained in the initial consultation and the assessment, we craft a detailed plan of action to resolve your issue(s).


6) Present and Discuss Plan with Management
We review the detailed plan of action with management and make revisions as agreed upon. The goal is to get your company in compliance as soon as possible.


7) Kickoff Workshop with Your Team (1 to 2 days)

  • We outline the process

  • Receive team buy-in from your staff

 

ROI for your company – As our tag line promises, “We Turn Compliance into Performance”


Click to schedule your complimentary consultation.

About Melita Ball

    Melita Ball is the Founder, CEO and Principal Consultant at MBC and Affiliates.  Twelve other extremely talented consultants work at MBCA under Melita’s direction. Each will be featured in a “spotlight” in our Compliance Corner newsletter.

     MBCA was founded in 2007 and has been helping Life Sciences companies stay out of regulatory difficulties ever since.

    

     Melita’s back story is very interesting. She grew up in Southern Virginia. After receiving her Master’s from The George Washington University, she decided to take a year off before pursuing a PhD in Philosophy.

     She ended up getting a job at Hollister, a Chicago based medical device company which had a fairly large manufacturing division in rural Virginia. That was in the early ‘90’s when ISO 9000 was a big deal. Melita decided not to pursue her PhD because she thought, "Hey, I'm building quality systems, so I'm using philosophy. I'm using a philosophical approach to how you build a system," and she was successful.

         

     Melita took a vacation and almost by accident vacationed in Tucson, AZ.  She loved Tucson, so she vowed to someday move there.  Eventually that worked out.

         

     A recruiter who knew she loved Tucson, called her and said, “There is a high-level position available in San Diego.  It’s not Tucson, but it’s closer than Virginia”.

         

     Melita flew to San Diego, went through 11 hours of interviews with 8 different staff members.  She flew a red eye to DC, drove 2 ½ hours home arriving in the morning. A couple of hours after getting home, she received a call offering her a great salary to make the move.  The caveat was she must report for duty in two weeks!

         

     She had built a house in Virginia on 2 ½ acres of land and moved in the year before. She decided to take a chance and make the move. She packed up everything, put her house on the market, and traveled across the country with her animals.  And there she was living in Southern California!

    

     The company was Alaris Medical Systems. Most of you probably know this company by a different name now (Carefusion, owned by Bectin Dickinson).

    

     Alaris, at that time, had compliance problems with the FDA. They had fired their CEO, hired a new CEO, and they were under consent decree with the FDA. They also had their design applications halted by the FDA, so they couldn't produce anything new. They couldn’t do a lot of things while this consent decree was in force. So, Melita's job, she learned very quickly, was to re-engineer the quality system and to get Alaris back on track from a regulatory perspective.

    

     She put a small team together within the company, and with the help of an outside consultant, assessed the entire quality system against the regulatory compliance requirements.  She had already done this for other companies except this time it was focused not just on ISO, but it was also focused on the FDA.

    

     After the assessment work, she started to work on the new and improved Quality Management System and was extremely successful. Alaris was a global company, so it wasn't just one site, they had sites in San Diego, the UK, and other locations around the world.

   

     The idea was to make sure they were compliant with the FDA, but more than that, they had to get their designs back in the pipeline and start performing again. To achieve this, they had to implement a new design control process to be not only compliant with the FDA requirements but also efficient.

    

     Once that was done, Melita took on an additional role of training in the organization. She was the trainer, but also responsible for global document and data control, which for Alaris, included all the engineering drawings and eproms used for data downloads for products.

    

     She inherited a group of folks that weren't performing very well, but she quickly got that turned around. And three years into the role, she had done what she’d come to do, things were working well, no one really needed her every day. It was one of those classic situations where she worked herself out of a job.

    

     Fast forward two years, and Alaris was hosting FDA inspections at their facilities and the FDA as actually using Alaris facilities to train new inspectors. That's how good the relationship was with Alaris Medical and the FDA.

    

     It is a true testament to Melita’s abilities that she was able to turn around the Alaris compliance issues in record time.  The Alaris success story alone is reason enough for companies to consider MBCA to aid them in their compliance issues.

    

     Now Melita was ready to start her quest again, for Tucson.

She moved to Tucson and found work with another medical device company. In 2006 she decided she wanted the challenge of setting up her own independent consulting business.

    

    Melita started as single-person consulting firm in 2006 and now has grown to 13 consultants strong, working all over the globe, helping clients either turn around their situation or helping clients get ready for inspections and audits.

    

     Melita and her staff love to train, do audits, perform mock FDA inspections and of course consult on compliance issues. They are very active in the Life Sciences industry.

 

Phone:

520.665.9081

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©2018 by MBC & Affiliates, Inc.