Validation

• Manufacturing Process Validation (PV): Bio, Vaccines, Pharma, Med Devices, Consumer Products
• Packaging Process Validation (Pkg V)
• Cleaning Validation (CV)
  • Cleanability Studies
  • Detergents Evaluation
  • Sanitizing Agents Studies
  • Recovery Studies
  • Microbial Load
  • Active Drug Solubilities and Sampling
  • Surfaces Areas and Sampling Points
  • Holding Times (Prior and Post Cleaning Process)
  • Worst Case Studies
  • Bracketing
  • New Approaches to Cleaning Validation
• Analytical Methods Validation (MV)
• Analytical Methods Transfer
• Software Validation and CSV
• 21 CFR Part 11
• Network / IT Infrastructure Validation
• Risk Based C&Q, Cleaning and Process Validation
• Validation Master Plans
• Process Support / Monitoring
• Maintenance of Validated Status: Verification vs. Validation?  We apply QRM most recent approaches 
• Revalidation

 Commissioning (C) and Qualification (Q)

• Green Building Commissioning
• Manufacturing and Packaging Equipment Qualification (IQ,OQ,PQ)
• Design Qualification (DQ)
• Maintenance System Qualification
• Utilities Qualification
• Facilities Qualification
• FAT / SAT
• Risk Assessment
• Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical
• Commissioning and Enhanced Commissioning
• Decommissioning
• Integrated Validation Approach
• Suppliers / Materials
• Personnel
• Instrumentation

Risk-Based Approach for Qualification

• Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
• Leverage testing from Commissioning (Enhanced Commissioning)
• Eliminate redundant paperwork during qualification
• Reduce test cases based on risk assessments
• Interpretation and Application of new standards based on Risk Based Approach
• Streamline practices and procedures
• Develop risk management exercises (e.g., FMEA)