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 Expert  726049

Expert in Validation


Available for your Consulting and Expert Witness Needs

Puerto Rico
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert has been an independent Validation Consultant for around 10 years; he is responsable for the management of validation projects. He supervises resources acting as a project manager and is also responsible for the development and execution of validation protocols, reports and investigation reports when required.
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21 CFR Part 11

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analytical chemistry

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bulk pharmaceutical chemical manufacturing

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drug regulation

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FDA food labeling regulation

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FDA limulus amebocyte lysate test regulation

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Food and Drug Administration regulation

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generic drug manufacturing

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investigational drug

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investigational drug procedures

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pharmaceutical capsule

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tablet manufacturing


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution   Honors
2000   MBA   Engineering Management   Politecnhic University of Puerto Rico   3.85GPA
1997   BS   Industrial Chemistry   University of Puerto Rico   3.00
  MS   Manufacturing Competitiveness   Politechnic University of Puerto RIco  

Work History:
Years   Employer   Department   Title   Responsibilities

2003 to

 

(Undisclosed)

 


 

Validation Consultant

 

He is responsable to manage validation projects. Supervise resources acting as a Project Manager. He is also responsible to develop and execute validation protocols, reports and investigation reports when required.

2002 to 2003

 

Foth & Van Dyke

 

Validation

 

Lead Validation Specialist

 

He was responsible to establis customer relationships with clients. He was responsible to supervize Validation Specialists. He was responsible to validate equipment, facilities and utilities according to clients needs.

1998 to 2002

 

Pharmacia formaly Pfizer

 

Manufacturing

 

Process Specialist

 

He was responsible to create Investigation Reports due to failures during the manufacturing and packaging process. He was responsible to validate equipment, facilities and utlities.


Career Accomplishments:
Associations/Societies

ACS, ISPE

Licenses/Certifications

Puerto Rico Chemical Liscense


Consulting Services:
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
Spanish   Native language

Additional Skills and Services:
Training/Seminars

He was invited to create presentation and teach to some validation activities of the Polytechnic Univertisy of Puerto Rico. He was also part of a consulting firm teching validation techniques to validation personnel.

Supplier and Vendor Location and Selection

He was in charge of creating new vendors relatinship


 

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