Process & Product Risk Assessments / Process Excellence / CPP & CQA Assessments / Technology and Product Transfer for the Pharmaceutical, Bio-Technology and Medical Device industries / Process Validation / Cleaning Validation / Computer Systems Validation (CSV) / Methods Validation / Technical Writing / Process Investigations / PPQ’s / IT and Network Infrastructure Validation / Process Monitoring & Support / Risk Based Approach / Re-validation / Validation Master Plans / Project Management

Instrumentation / Manufacturing, Packaging and Laboratory Equipment Qualification (IQ,OQ,PQ) / Commissioning and Enhanced Commissioning / Decommissioning / Facilities – Utilities Qualification / Factory Acceptance Test (FAT) / Site Acceptance Test (SAT) / Engineering Maintenance System Qualification / Risk Assessment – Management / Steam in Place (SIP) Validation

Project Management (PM) / Capital Projects / Process Engineering / Project Planning & Development / Disaster Recovery and Hazard Mitigation: (Implementation and Strategic Management of Projects under FEMA Public Assistance / FEMA Section 428 for Puerto Rico / FEMA 406 Hazard Mitigation and 404 Hazard Mitigation / Use of tools and Grants Portal / Use of COR3 DRS Tool) / Spare Parts Maintenance Systems / Plant Start Up / Critical Utilities Monitoring and Audit / Facility Integration / Clean Steam Generation and Distribution / Autoclaves / Laboratory Systems / Purified Water and DI Water Generation and Distribution / HVAC / Air Compressors / Clean Air

Quality Risk Management (QRM): Strong background in Continued Process Verification (CPV) based on current 2011 Validation Guidance / Risk Based Validation / ICH Q9 Guidelines / Annual Product Reviews (APR’s) / Batch Records Reviews / Compliance Assessments / Change Controls Generation / Complaint Reports and Investigations / CAPA / Validation & Qualification Documents Assessment / GAP Analysis / Remediation Plans / Audits / Pre-approval Inspections (PAI) / Quality Systems Compliance / Regulatory Consulting / Stability Protocols and Stability Programs / Standard Operating Procedures (SOP’s) Development

Continuous Manufacturing / Corrective Action and Preventive Action Plans (CAPA) / pFMEA / Operations Related Investigations / Optimization Process / Process Support (OSD, Parenteral Products and Medical Devices) / Packaging Technologies / Process Improvements – Monitoring / SOP’s & Batch Records Review / Quality Engineering / Risk Assessment – Analysis / Statistical Process Control (SPC) Tools / Process Excellence / Track-n-Trace Serialization / Process Automation