Many of us probably never consider the number of Food and Drug Administration regulations that play a part in our everyday lives, especially those for the pharmaceutical and biotech industries. But for Andy Ferrell ’90, ’93
, president and CEO of Pharmaceutical Calibrations and Instrumentation, LLC, these regulations are always on his mind and are what keep his business going strong.
Founded by Ferrell in 1996 based on his graduate thesis “Contract Calibration Services for the Pharmaceutical Industry,” PCI is a consulting and technical services firm that supports life science companies with instrumentation, calibration, and cGMP (current Good Manufacturing Practices) compliance programs. PCI specializes in instrument maintenance, calibration program implementation, process and laboratory instrument calibration, and preventative maintenance. These services meet federal regulations involving instrumentation management and documentation, and help PCI’s clients reduce service costs, enhance operations, and improve overall compliance.
You may be wondering what PCI has to do with you? More than you know. Think of the last medication you took for the flu, high cholesterol, or even just a headache. Each of these drugs has been approved by the FDA for its specified use. The instruments used by pharmaceutical companies to calculate and produce exact dosages of these drugs require constant calibration, monitoring, and maintenance to remain compliant with the FDA. Incompliance could result in massive fines, lawsuits, drug recalls for a company, and severe illness or worse for consumers. PCI helps pharmaceutical and biotech companies remain compliant and keeps consumers safe by ensuring that the instruments used by these companies—ones that measure parameters like temperature, pressure, volume, weight, humidity, air flow—are performing at their government-regulated standard.
But there’s more to PCI than calibration services. It also offers a metrology lab with extensive calibration capabilities; consulting for audits, training, and program development; data management of calibration and maintenance programs; and program management for entire facilities or specific departments. PCI currently serves more than 160 companies in the continental United States, Canada, and Puerto Rico—Glaxo Smith Kline, Eli Lilly, and Pfizer, just to name a few. Its headquarters are in Raleigh, North Carolina, with offices in Michigan and Indiana, and local presence in Atlanta, Baltimore, Boston, and Indianapolis. PCI will also step in during a crisis, like a drug recall, to get a company back on track with meeting FDA regulations. Although there is not tremendous competition in the market, to keep their competitive edge PCI introduced a virtual calibration department concept in 2008.
The company is also unique in its approach to employees (referred to as “associates”) as it doesn’t have human resources or sales departments. “We don’t like the term employee; it implies subordination,” said Ferrell. “We train and empower our associates to promote our business so we don’t need a sales force. We have a solid benefits package (almost a requirement to compete with Big Pharma) and we employ high-tech tools to administer 401k and medical, eliminating the need for an HR department.”
Another reason why PCI doesn’t need an HR department is its reputation in its narrow market as a company that is passionate about developing resources. During graduate school, Ferrell enjoyed teaching technical writing and has implemented his love of learning into his business. PCI offers many internal training programs for its associates as well as its clients. Its headquarters is even equipped to provide multimedia satellite training and video conferencing for clients and associates. “What I like most about PCI is that I get to work with great customers and great people. We have assembled a staff that is the best of the best,” commented Ferrell.
Originally from Wilson, North Carolina, Ferrell is also fervent about ECU, which he chose to attend over UNC-Chapel Hill and NC State. He was the first in his family to attend college and received a North Carolina Veterans Affairs scholarship, “without which I am not sure I would have even gone to college, ” said Ferrell. His father served in Vietnam, was shot, and is considered partially disabled. “My scholarship was very important and one of the reasons I am passionate about funding a scholarship at ECU,” said Ferrell. The Laura and Andy Ferrell Endowment Scholarship, which was created in 2010 and is the first of its kind, will be awarded annually to a student in the College of Technology and Computer Sciences from the Engineering Department. Ferrell’s commitment to ECU includes offering co-op opportunities for engineering students at PCI, serving as a board member for the University’s Medical & Health Sciences Foundation, as an Advancement Council member for the College of Technology & Computer Science, and as an Advisory Board member for the Engineering Department. He also occasionally speaks and gives presentations to engineering classes. “At some point, whenever I quit this business or retire at some level, I’d like to go back to teaching,” remarked Ferrell. Another good reason he stays connected with ECU.
In his spare time, Ferrell serves on the American Heart Association Triangle Area Executive Leadership Team, plays tennis, and is an avid fly fisherman. He and wife Laura have two daughters Savannah and Summer.