The pharmaceutical industry today is challenged by the need to keep up with advances in science and technology, as well as changing regulatory and compliance issues. Success demands highly skilled validation professionals who not only understand the interdependence of multiple technologies, but the complex integration practices required, and their impact on validation. Such skills are especially important with computer systems validation (CSV; see COMPUTER VALIDATION sidebar below).To address the need for ongoing training in validation, many scientific and engineering professional associations, such as ISPE, have developed programs designed to ensure competence in key areas of practice. Within Puerto Rico, industry leaders have gone one step further, by establishing a “Validation Academy” within the Polytechnic University of Puerto Rico’s Continuing Education Department. After pilots, the program was officially launched on January 1.Faculty within the University, concerned consultants and professionals within the industry believe that this program will be essential to fostering the professional growth of validation professionals. The program should also help validation specialists document their specific areas of expertise and sharpen their skills through additional education and training.Certification as a Validation Professional is voluntary. However, as validation activities become more critical, we believe that more pharmaceutical companies will encourage their validation professionals to pursue certification.The program will recognize professionals who meet basic eligibility requirements and demonstrate a minimal level of job-related knowledge and skills, based on performance in a standardized examination. To be eligible, one must have a bachelor’s degree in science and three years of experience in pharmaceutical industry validation. For individuals with a significant amount of validation experience, a “grandfather clause” applies, allowing them to receive certification simply by passing a formal examination. (Editor's Note: What's your validation IQ? Test yourself by answering the four sample questions (provided at the end of this article) from a test developed as part of Puerto Rico Polytechnic’s new certification program. The answers may be found by clicking here.)Faculty members — expert consultants and industry professionals — have identified areas of competency and the knowledge and skills required for each one, and have written test questions targeting these areas. Certification candidates might be asked to:
After completing a General Concepts module, applicants must complete a specialized module of their choice, and their associated examinations for certification as a validation specialist. Once an individual has completed all eight modules within the course, and their associated exams, they will receive a Validation Professional certificate.The University will issue certification for a three-year period, and those receiving certification will need to keep up to date on new developments within the field, and build competency through continuing education. Every three years, certified professionals will have to take courses adding up to 14 “Recertification Units” in order to be recertified.
Ivan Lugo, M.S., is Executive Director of INDUNIV Research Consortium, a 20-year-old, not-for-profit organization dedicated to promoting industry competitiveness through knowledge creation and the development of centers of excellence (www.induniv.org).Magaly Vega, Ph.D., is a Professor at Polytechnic University of Puerto Rico and owner of Pharmedia Compliance Consulltants. She has over 30 years of experience in the pharmaceutical industry.José E. Correa, P.E., is General Manager of the Puerto Rico office of Taratec Development Corp. He has an extensive background in project management, validation and quality systems.VALIDATION QUIZ:
- Develop a list of User Requirements for a given scenario;
- Develop test scripts for a given source code;
- Use data provided to develop a Traceability Matrix.
Validation Academy Curriculum Modules | General Concepts Module Topics |
1. General Concepts | 1. Basic Validation Concepts and Documentation |
2. Computer Systems | 2. Qualification Studies: Facilities, Utilities & Equipment |
3. Pharmaceutical Process Technology: Solids | 3. Regulatory Trends |
4. Pharmaceutical Process Technology: Parenterals | 4. Supplier Certification |
5. Validation of Analytical Methods | 5. Risk Management |
6. Biotechnology | 6. Cleaning Validation |
7. Medical Devices | 7. Statistical and Validation Matrix Approach Topics |
8. Packaging |
Ivan Lugo, M.S., is Executive Director of INDUNIV Research Consortium, a 20-year-old, not-for-profit organization dedicated to promoting industry competitiveness through knowledge creation and the development of centers of excellence (www.induniv.org).Magaly Vega, Ph.D., is a Professor at Polytechnic University of Puerto Rico and owner of Pharmedia Compliance Consulltants. She has over 30 years of experience in the pharmaceutical industry.José E. Correa, P.E., is General Manager of the Puerto Rico office of Taratec Development Corp. He has an extensive background in project management, validation and quality systems.VALIDATION QUIZ: