Validation Management
Engineers and Managers
- Validation Master Planning
- Process Automation Systems
- Manufacturing Facility Systems
- Computerized/ Information Systems
- Equipment Qualification
- (Manufacturing and Lab Systems)
- LIMS / Stand Alone Lab Equipment
Auditing
Certified Audit Leads
- Quality Systems
- Investigator Sites
- Manufacturing Suppliers
- Clinical Service Providers
- Operational Internal Controls
- Clinical Research Organizations
- Data Integrity Program Assessments
- Information Systems- Third Party Vendors
- Computerized System Assurance (CSA) Program Assessments
Quality
Experienced Quality Professionals
- Quality Auditing
- Quality Engineering
- Quality Management
- Quality by Design (QbD)
- Quality Assurance (batch release)
- Risk-Based Quality Management (RBQM) for Clinical Trials
Consulting
Improving your business execution and performance
- Consent Decree Remediation
- Part 11 Data Management
-
Operational Excellence
(Lean Event Management) -
Quality Management System
(Efficiency and Cost Evaluation)