Program Partner

Member Benefits on FDA/Regulatory Services

10% discount on all professional services, such as:

• Commissioning, Qualification and Validation (CQV) Planning, Document Generation and Execution Support
  • Factory Acceptance Testing (FAT’s)
  • Review and Preparation of Validation Master Plans
  • Writing CQV Plans / Generating CQV documentation (IQOQ PQ) / Executing CQV documents
  • Facility, utility, and equipment CQV protocol execution
  • Resolving Deviations / Change Management
  • Writing Final Summary reports
     
• Computer System Validation and Assurance, and IT Infrastructure support
  • eQMS System Validation and Integration
  • ERP (such as SAP) Validation and Integration / BMS Validation and Integration (Delta-V, Siemens, etc..)
  • Data Integrity Gap Assessments/Audits
  • Serialization support for packaging regulations (Validation and Integration)
     
• Regulatory Affairs
  • Regulatory Strategy
  • Provide Guidance on Regulations and Standards / Generate and Manage Submission Files and Review 
  • Review and Maintain Project Documentation and Records
  • Participate in Risk-Benefit Analysis for Regulatory Compliance / Gap Assessment and Audits
     
• Quality Assurance
  • QA Oversight - Investigations / Non-Conformance Reports / CAPA’s / Change Control / Training Compliance, Training and Support / Quality Agreements / SOP writing
  • Review and Approval of Validation Documents
  • Regulatory Inspection Remediations / Regulatory Documentation
     
• Audits and Gap Analysis 
  • Supplier 
  • Turn-Key Supplier Qualification Program Support
  • Safety 
  • Laboratory
  • Facility
  • PAI Preparation
  • cGxP
  • Gap Analysis
     
• Calibration
  • Field instrument calibrations
  • Calibrations in our metrology laboratory
  • Equipment rentals
  • Thermal mapping
  • Equipment Commissioning (Factory and Site Acceptance Tests)
     
• Engineering
  • Engineering Support – Drawings / SOPs / Redline P&IDs / URS development
  • Support Preventative Maintenance and Product Specifications 
  • Provide Certification Programs for Capital Projects and Lifecycle Management for Process, Facility, and Utility Systems
  • Technical Writing - SOPs / LOTO Procedures / Global Harmonization / Risk Assessments / Training documentation creation and performing training
     
• Project Management (Fractional or Full time)
  • Planning and Managing complex capital projects
  • Commissioning Qualification Validation projects
  • Construction Punchlist
  • And more

 

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Member benefits, exclusive discounts, and more.