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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:
-
Have a specified level of education:
At least a Bachelor’s
degree in Science or Engineering from an Accredited
Institution.
-
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.
-
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:
-
Have a specified level of education:
At least a Bachelor’s
degree in Science or Engineering from an Accredited
Institution.
-
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
-
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.
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