Text Box: Pharmaceutical Validation Engineering, 6 Six Sigma – Black Belt & Lean Manufacturing, Engineering Project Management, Regulatory Compliance, Audits & Investigations, Instrument Leasing: GE KAYE Validator 2000, Contract Manufacturing, Incubators, Freezers, Construction Design, Moving support, Business Opportunities, Aerospace design, Commercialization new products, Certified Minority Business Enterprise,

Corporate tel: 787-892-0516

Corporate fax: 787-892-3521

E-mail:

 

Text Box: Contract Manufacturing
Text Box: Instrument Leasing
GE KAYE Validators: Temperature Sensors, etc.

  CAPA Investigations & OOS Reports

  Risk Assessments—Regulatory

  Annual Product Reviews

  QA Regulatory Audits & Trainings

  PAT Implementation

  Counterfeit Prevention & Investigations

  Calibration Program Assessments

  Recall Investigations

  Final Summary—Executive Reports—

   Computer Validation: VP/URS/FRS/DS/TM/IQ/OQ/PQ

   Engineering Commissioning: SATs and FATs

   Utilities Qualification: HVAC, Compress Air, etc.

   Facilities Qualification: FQ

   Process Validation, re-qualification: IQ/OQ/PQ

   Design Qualification: — DQ

   Investigations, SOP,s, PM, Spare Part List

   Thermal Mapping & Sterilization Runs

   Packaging and Process Validations

   Lyophilization Validation

   Cleaning Validation

 

  Project Planning & Presentations

  Project Management & Control

  Construction Supervision

  Commissioning Activities

  Consulting Project Auditing

  Maintenance Services

  Safety and Health Security Management

  Pest Control Management

  SOP & Preventive Procedures Preparation

  Control System Installation/configuration—

  Cost Analysis Management

  Evaluación de Riesgos y Áreas de Mejoras