General Validation Presentation
- 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
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