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General Validation Presentation

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  • 1.  
  • 2.
    • Published safety program
    • Safety officer is Principal of firm
    • Conformance to client standards
    Safety
  • 3.
    • Our Mission
    • We deliver services and products that enable our clients to achieve a higher level of success
    • Our Goals
    • Maximize your benefits and minimize the costs of complying with current Good Manufacturing Practices (cGMP)
    • Provide quality services allowing clients to deliver their products to market faster
    • Utilize innovation and technology to maximize efficiency and effectiveness
  • 4. MD Employees 10 MD Consultants 12 PA Employees 7 PA Consultants 2 MA Employees 1 MA Consultants 2 Administration 4 Total Staff 38
  • 5. “ What we need to do is learn to work in the system, by which I mean that everybody, every team, every platform, every division, every component is there not for individual competitive profit or recognition, but for contribution to the system as a whole on a win-win basis” -W. Edwards Deming
  • 6. Owner Validation, Inc. Project Team
  • 7.
    • Principal involvement & commitment
    • Effective evaluation of alternatives and investigative solutions
    • Project management involvement from detail design to Process Validation
    • Sensitivity for existing operations
    • Understanding Client Standards
    • Responsive and cost conscious
    • Proactive
    The Validation, Inc Difference
  • 8.
    • Establish and maintain long term relationships with our clients based on trust, integrity and accountability
    • This commitment has resulted in repeat business of >90% with our valued clients
    The Validation, Inc Culture
  • 9.
    • Scheduled kick-off meeting
    • Effective communication
    • Project scheduling
    • Resource management
    • Project controls
    • Weekly status reports
    Project Management
  • 10. Our
  • 11. SERVICES Our
    • Detail Design Review
    • Commissioning
    • Calibration/Maintenance Management
    • Equipment Qualification
    • Process Validation
    • Cleaning Validation
    • Computer System Validation
    • Analytical Instrument Qualification
    • Analytical Assay Development
    • PAI Readiness
    Services
  • 12.
    • We provide commissioning documents that result in a complete Engineering Turn-over Package (ETOP) that is considered the point of delivery into the qualification effort.
    • Leverage commissioning knowledge to accelerate the qualification process
    • Develop and execute commissioning plans
    • Develop commissioning documents (e.g. User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests)
    • Witness vendor commissioning activities
    • Manage the commissioning activities of vendors, contractors, and system owners
    Commissioning and Start-Up
  • 13.
    • Calibration Program Review
    • Proactive deviation reduction
      • Process tolerance review
      • Actual vs. validated vs. calibrated
    • Deviation investigation and resolution
    • Shutdown coordination
    Calibration/Maintenance Management
  • 14.
    • We have the experience to validate most manufacturing equipment or supporting utility system.
    • Validation Master Plans
    • Leverage commissioning information into IQ/OQ
    • Installation Qualifications
    • Standard Operating Procedures (SOPs)
    • Operational Qualifications
    • Performance Qualifications
    • Final Reports
    Equipment Qualification
  • 15.
    • Fit-For-Use Approach to Verification – Key Elements
    • Identification of risks with respect to patient risk
    • Appropriate level of verification given the risk
    • Focus on important issues with approved documents
    • Critical Quality Attributes
    • Critical Process Parameters
    ASTM E-2500
  • 16.
    • Focused efforts up front in process to diminish downstream work
    • Good Engineering Practices
    • Vendor support documents
    • Identify Subject Matter Experts to support project
    • Summarize process for each system and prepare written justification
    • Eliminate redundant testing
    ASTM E-2500
  • 17.
    • Our validation consultants have experience validating processes in all disciplines of the FDA regulated industries.
    • Review development reports to determine the critical processing steps and quality attributes
    • Develop scientifically justified validation plans, which demonstrate consistency and reliability in processing
    • Assist in developing statistically justified in-process and finished product sampling strategies.
    Process Validation
  • 18.
    • We have the expertise to guide you through the Cleaning Validation process.
    • Establish a Cleaning Master Plan
    • Set residual acceptance criteria
    • Prepare a comprehensive sampling plan
    • Validate and use appropriate analytical methods
    Cleaning Validation
  • 19.
    • We provide training programs to meet our specific customers' needs by pulling from our extensive knowledge base of compliance, quality systems and validation.
    • Our Training Programs:
    • Compliance with Current Regulations
    • GAMP 5
    • Establishing Quality Systems for System Development Life Cycle Management
    • Good Documentation Practices
    Training
  • 20.
    • Our approach includes an audit against internal practices and GxP Regulations.
    • Identify all systems that fall under GxP regulation
    • Conduct gap analysis
    • Develop a risk analysis for each system
    • Prioritize the systems based upon the risk analysis
    • Develop an action plan to address non-compliance
    • Schedule and execute the action plan
    Compliance/PAI Readiness
  • 21.
    • ISPE
      • Chesapeake Bay – Board of Directors
      • Delaware Valley
      • New Jersey
    • PDA
    • ASQ
    • PMI
    Associations
  • 22.
    • Genesis Engineers, Inc. – MEP Engineering
    • MicroBiological Environments – Lab Analysis
    • ENV – Calibration and Certification
    • DCI – Vessel/CIP System Manufacture
    Strategic Alliances
  • 23.
    • What are your current needs?
    • Process
    • Utilities
    • Analytical
    • Calibration Management
  • 24. ? ? ?