Validation Certification* - Certification Requirements

Requirements for Certification* as Validation Specialist

Polytechnic University of Puerto Rico awards Validation Specialist Certification in selected area(s) of practice to candidates who meet the following criteria:

1. Have a specified level of education: At least a Bachelor’s degree in Science or Engineering from an Accredited Institution.
   
   
2. Provide proof of job experience and professionalism: At least 3 years of demonstrated practical experience working as a validation professional in the specialized area of interest.
   
   
3. Demonstrate competence in the Validation Certification Body of Knowledge: Attend the Validation Certification Academia (General Module and Selected Area(s) of Interest Module) and pass the examination in the General Module and the selected Area of Specialization Modules. Exams will be based in a)The Body of Knowledge; b)Material presented and discussed in the Validation Academia; 3)The references of study and consultation presented during the academia. The minimum passing grade to receive certification is 70% for both the General Module Exam and the Specialized Area of Certification Modules.

*Certifications as Validation Specialist are valid for a period of three (3) years. In order to make sure Validation Specialists keep up to-date with new developments and requierements in the subject matter, re-certification is requiered every three (3) years.

Requirements for Certification as Validation Professional**

Polytechnic University of Puerto Rico awards Validation Specialist** into candidates who meet the following criteria:

1. Have a specified level of education: At least a Bachelor’s degree in Science or Engineering from an Accredited Institution.
   
   
2. Provide proof of job experience and professionalism: At least 3 years of demonstrated practical experience working as a validation professional in a minimum of 3 of the following areas of specialization:
   
   
   • Computer Systems Qualification/Validation
     
   • Pharm Tech : Solids (Process and Packaging)
     
   • Pharm Tech : Parenterals (Process and Packaging)
     
   • Validation of Analytical Methods
     
   • Biotechnology
     
   • Medical Devices
     
     
3. Demonstrate competence in Validation Certification Body of Knowledge : Attend the Validation Certification Academy (General Module and All Area of Interest Modules) and pass the examinations in the General Module and the exams in each one of the Area of Specialization Modules. Exams will be based in a)The Body of Knowledge; b)Material presented and discussed in the Validation Academia; 3)The references of study and consultation presented during the academia. The minimum passing grade to receive certification is 70% for both the General Module Exam and the Specialized Area of Certification Modules.

**Certifications as Validation Professional are valid for a period of three (3) years. In order to make sure Validation Professionals keep up to-date with new developments and requierements in the subject matter, re-certification is requiered every three (3) years.