|
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
|
Date
|
- Computer Systems Qualification
&Validation
- Pharm Tech II: Solids
|
Proctors
|
S
|
TBD
|
- Biotechnology
- Packaging Validation
|
Proctors
|
S
|
TBD
|
|
