BY JAMES FERRÉ
“Human capital is the most important asset and the main contributor to quality,” said Enid T. Vargas Maldonado in a recent interview with CARIBBEAN BUSINESS. “If we want to get the best results, more attention and investment is required in the implementation of quality programs.”
For this reason, a pharmaceutical company must prepare its resources, including human resources, according to industry best practices to insure quality programs and procedures.
For Vargas and Elizabeth Plaza, partners at PharmaServ Academy, the training division of PharmaBioServ, quality involves continuously identifying and applying best practices and standards. As Plaza says, “Quality must be a living program.”
Plaza, the president of Pharma-Bio Serv, explained that quality starts with the design and development of a program that covers the implementation of a given procedure. However, the program must also cover the training of employees for the deployment of the procedure, and include continuous monitoring and review by regulatory organizations.
“It is the continuous monitoring and review that ensures that the procedures and systems remain current and effective,” said Plaza, explaining that it is in this role that project managers come in, as they have the needed leadership skills to understand how to manage change and the diverse elements of quality control.
Most of the issues both regulators and industries deal with revolve around the lack of continuous improvement processes and training that leads to human error, explained Plaza, who believes in prevention over remediation.
“The cost of preventing mistakes is generally much less than the cost of correcting them,” said Vargas, founder and president of the Puerto Rico chapter of the Project Management Institute.
Added Plaza, “In the case of the pharmaceutical industry, we could say the cost of noncompliance is much higher than the cost of investing in quality systems and keeping them current to the changing needs of the consumer, the regulators, and the global trends. Our consulting and training programs do just that.”
The academy provides educational programs on best practices in the areas of change management, project management and leadership, allowing their students to apply and/or to obtain certifi cation in those areas.
The objective of the academy, Plaza explained, is to help its clients remain in compliance and prevent quality issues by implementing effective quality systems and providing continuous training to clients’ employees.
Furthermore, PharmaServ Academy and PharmaBioServ not only support their clients’ compliance initiatives, but also provide advice and recommendations to help them stay ahead of the curve, as both Vargas and Plaza, both active participants in regulatory and professional organization forums, consistently bring the latest in best practices to their customers.
Plaza is a pharmacist who studied at the Quality Engineering Academy and in the entrepreneurship development program at MIT as well as the Kellogg School of Business advanced management development program.
Vargas earned a master’s degree in business administration from Florida Metropolitan University and a master’s certifi cate in project management from George Washington University. She is the only Latin American woman recognized by the Project Management Institute as one of the world’s “25 Most Influential Women in Project Management.”