Site Content
Package Design
Verification / Validation
Material Selection
Primary Sterile Barrier System
Protective Packaging
Secondary Packaging
Tertiary / Distribution Packaging
Labeling/Marking
Material Selection
Verification / Validation
Material Selection
Device Contact Materials
Sterilization Compatibility
Bio-compatibility
Accelerated Aging / Stability Studies
Supplier Selection
Physical Properties
Sustainability
Customer Requirements
Cost Savings
Verification / Validation
Verification / Validation
Verification / Validation
Design Verification
Process Development (DOE)
Process Capability Runs (Cpk, Ppk)
Equipment Installation (EQ/IQ)
Process Validation (OQ/PQ)
Label System Validation
Feasibility
Project Management
Verification / Validation
Prototypes
Feasibility Testing
Customer Evaluations
Plant Pilot Runs
Cost Analysis
Risk Assessment
Project Management
Project Management
Risk Management Plans
DFMEA's
PFMEA's
DCTM
UFMEA
Process Mapping
Supplier Assessments
Process Capability
Business Continuity
Compliance Risks
Project Management
Project Management
Project Management
Project Leadership
Interim Management
Technical Leads
Team resourcing
3rd Party Coordination