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Validation Certification - Calendar

VALIDATION CERTIFICATION ACADEMY SCHEDULE March 2008

GENERAL MODULE

Topics Instructors Days Dates
1. Basic Validation Concepts and Documentation Magaly Vega, PhD, RPh F, S March 7,8
2. Qualification Studies: Facilities, Utilities & Equipment Magaly Vega, PhD, RPh F, S March 14,15
3. Regulatory Trends TBD S March 29
4. Supplier Certification Heriberto Lorenzo, BSIE S April 5
5. Risk Management Carlos Urrutia, ET, BSME F, S April 11,12
6. Cleaning Validation Vilmary Negrón, BSChE, MSChE S April 19
7. Statistical and Validation Matrix Approach Topics Vilmary Negrón, BSChE, MSChE S April 26
Exam Proctors S August 16

*Tentative Program


VALIDATION CERTIFICATION ACADEMY SCHEDULE October 2008

Specialized Certification Modules Exams for Certification as Validation Specialist and Validation Professional

Modules Instructors Days Dates
1- Computer Systems Qualification & Validation José Correa, PE, MBA S October 2008
2- Pharm Tech I: Parenterals TBD No Available
3- Pharm Tech II: Solids Magaly Vega , PhD, RPh F, S October 2008
4- Packaging Validation Cesar Hernández, PE, BSIE F, S October 2008
5- Medical Devices Carlos Urrutia, ET, BSME No Available
6- Biotechnology TBD F, S October 2008
7- Validation of Analytical Methods Warren L. Oms, BSCh No Available

*Tentative Program

Exams for Certification as Validation Specialist and Validation Professional

Certifications Instructors Days Dates
- Computer Systems
- Qualification &Validation
- Pharm Tech II: Solids
Proctors S TBD

- Biotechnology
- Packaging Validation

Proctors S TBD
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