PharmaView: The Few, the Proud, the Certified

ISPE’s Certified Pharmaceutical Industry Professional (CPIP) certification program is (as it should be) only for those who enjoy a challenge.

By Paul Thomas, Senior Editor

Accomplishments don’t mean much unless there’s some exclusivity attached to them. As a boy, I thought it was pretty cool when I got my cub scout fire safety badge, until I found out that Timmy McGrath got his, too, and he didn’t even study—unless you call playing with fire studying. (Timmy was the neighborhood pyromaniac.)

So it goes for professional certifications. Unless they’ve got some exclusivity, they’re not worth the paper they’re printed on. In establishing its Certified Pharmaceutical Industry Professional (CPIP) program, ISPE has made sure that the journey to certification is no walk in the park.

Not everyone is eligible. You’ve got to have a valid science or engineering degree and/or 10 years of industry experience to be considered in the first place, and the program itself has rigor (www.ispe-pcc.org/.) It requires participants to exhibit knowledge and skills in areas such as leadership, change management, quality and continuous improvement, as well as technical knowledge in seven categories: 
1.    Product development
2.    Facilities and equipment
3.    Information systems
4.    Supply chain management
5.    Production systems
6.    Regulatory compliance (includes drugs, EH&S)
7.    Quality systems

CPIP is billed as the “first global competency-based professional certification to be offered to the pharmaceutical industry covering development through manufacturing.” (ASQ’s Certified Pharmaceutical GMP Professional program, as its name implies, focuses more on manufacturing practices.)

Some of the first CPIP grads are now (forgive the metaphor) rolling off the production line. Two are Sam DeMarco and Peter Werner Christiansen.

DeMarco, a consultant and president of Compliance Team, Inc., made getting the CPIP a goal since he first heard about the program, as a way of establishing credibility and getting involved in the thick of discussions over key industry issues. He was surprised by the time and effort required to complete certification. “It is a rigorous program because of the amount of time you need to invest in writing about your technical knowledge and experience for each selected exemplar and the effort needed to get approved to take the test,” DeMarco says.

So you just need to hit the books, is that it? Hardly, says DeMarco. “I do not believe that anyone can meet the stringent requirements of the CPIP program without having a broad scope of real experiences in the industry over many years. You can not study your way through this credential—you must have the real-life experience that only time can give you.”

Christiansen, a senior quality professional with NNE Pharmaplan A/S, concurs. Only because of his some 30 years in the industry could he survive the program, he says, and even then he had to round out his knowledge of the seven key technical areas. “I was lucky to have a broad background,” he says.

CPIP is a competency-based certification, but even the most experienced professionals will have skills gaps to overcome. There were a few knowledge elements outside his expertise, DeMarco acknowledges—supply chain management and information systems, for example. “I created a self-study plan for the elements outside of my center of knowledge,” he says. “I may have over-studied to make sure that I covered the subject element well—and the test questions were very difficult in these areas for me.”

With his certification in tow, DeMarco aims to pass on the knowledge he’s gained, helping to educate and train the next wave of industry professionals, he says. As a start, he advises others seeking certification to assess the breadth of their experiences and competencies against the four core competencies of the program. That is, don’t dive in until you’ve accumulated a wealth of experiences in different functional areas.

Christiansen isn’t sure where his CPIP will lead him. He got into the program as a way of testing his knowledge of the industry, but has found that it has prepared him to be a better speaker, presenter, and well-rounded professional in general. “I have a more structured and clear picture of the whole pharma area,” he says, “and I also have proof that this picture is true.”

The program isn’t for everyone, Christiansen adds. It should be undertaken by those who have clear career goals and a good sense of how CPIP will benefit them. And it’s good for those who want to create change, “because that is what you will want to do when you have all this knowledge and experience.”

Did you hear that, Timmy McGrath?

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