Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Pharmaceutical Professional with over 20 years of solid technical and compliance knowledge in all aspects of manufacturing, cGMP compliance, regulatory compliance, validation, equipment validation ( including tablet presses and coaters, granulation equipment, liquid fillers, high shear mixers, PLC, and SCADA), sterile processes, quality assurance, gaps in processes and procedures, packing configuration, temperature controlled shipping, cold chain procedures, global shipping protocols, Experience working in top global pharmaceutical and biologics manufacturing companies. Background in vaccines, live virus vaccines, liquid pharmaceuticals and sprays, tablets, generics, dosage variations, antacids, excipients, oral disbursables, and combination products.

CORE COMPETENCIES

  • Risk Management/FMEA/SWIFT Assessments
  • Factory Acceptance Testing/Site Acceptance Testing
  • Commissioning and Qualification
  • IQ, OQ and PQ, Generation/Execution
  • SOP Development and Generation
  • Equipment and CSV (Enterprise/Automation) Validation
  • Process/Utility/CIP and SIP Validation
  • Building Automation Systems (BAS/BMS)
  • Temp/RH Studies (Chambers, Warehouse, Transportation)
  • Installation of Temp Monitoring Systems
  • 5 S / Kaizen / Kanban / Right the First Time (RTF)
  • Change Initiatives/Change Controls
  • Quality System Development/Support/Auditing
  • Training/Training Materials/Assessments/Facilitation
  • FDA regulations, ICH Guidelines Q Series, PDA Technical Reports, GAMP5, ASTM E2500
  • Site and Global Project Implementation Experience
  • Electronic Document Systems (Trackwise/Documentum)
  • 100% Completion Metrics (Time/Budget/Resources)
  • CAPA, Deviation and Non-Conformance Reporting Quality Assurance/Regulatory Affairs
  • Project Management/Leadership

SELECTED ACCOMPLISHMENTS

  • Consent Decree CSV Remediation project activities for an OTC product manufacturer, including:
    • Provided Consent Decree Step Lead project management. Activities included the targeted remediation of all computer system (CSV) related equipment on the manufacturing site (Fill/Finish/Packaging).
    • Remediation of liquid, solid and packaging lines (CSV equipment automation and site enterprise systems), including gap assessments and summary reports, change controls, quality risk management documentation, functional/user requirements, protocol generation and execution, traceability matrices and final verification with third party auditor. Leadership activities included, document matrices, coordination with site base business and CD management coordination of timeline, resources and deliverables.
  • Pilot Plant Start-Up Qualification and Validation activities for an OTC product manufacturer, including:
    • Provided senior level consulting for new R&D pilot plant start-up.
    • Participated in Factory Acceptance Testing and Site Acceptance Testing for solids and liquids processing, USP water system, clean steam generation and utility systems.
    • Prepared and executed Installation, Operational (IOQ) and Performance (PQ) documentation for new solids processing equipment and USP water system.
    • Equipment validation included mixing, blending and granulation equipment, tablet presses, tablet coater, scales, liquid filler, glass washer and laboratory equipment. Water system consisted of generation and distribution.
    • Utility validation included compressed air system, steam generator, HVAC system and building automation system upgrades.
  • Global shipping qualification responsibility efforts for high-profile pharmaceutical, manufacturer of generic products, including:
    • Designed, implemented and executed a Cold Chain Shipping Qualification for worldwide product distribution (+200 products, Temperature Ranges of -80°C, -25°C and 2-8°C).
    • Generation of Validation Master Plan, protocols, risk assessments, SOP’s and reports to qualify the shipping of temperature controlled product from bulk manufacturing site to the filling and packaging site to the distribution site to the final customer.
    • Designed and executed packing configuration and coordination of global shipping protocols.
    • Efforts included; warehouse thermal mapping, packaging thermal studies, thermal shipping studies and datalogger/testing equipment management.
    • Revision of all concurrent SOP’s concerning the temperature stability of product from storage, manufacture and distribution.
    • Revision and implementation of cold chain procedures for manufacture storage and global distribution of temperature sensitive product.
    • Protocols and documentation were executed across multiple sites and multiple products, including facilitation of meetings with thermal qualifications in UK, Canada, and Japan, preparation of minutes to track action items, mitigation of risks to project timelines, and reporting of progress and risks to upper management.
  • Processing validation responsibility efforts for high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Participated in the design, coordination, and timely execution of multiple simultaneous validation studies for new and existing equipment for the manufacture and release of commercial and clinical vaccines.
    • Assisted with assessment of equipment systems via P&ID Walk-Down.
    • Provided support for commissioning of equipment during the new vaccine campaigns; IOQ, PQ and final report preparation.
    • Validation execution of SIP/CIP sterile processes and new cleaning paths.
    • Participated in validation of equipment automation; PLC and SCADA.
  • Senior Consulting responsibility effort for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Generation of new corporate Quality System Element for Validation.
    • Performed gap analysis and quality risk assessments of current systems.
    • Remediated risks through new corporate guidelines and procedures.
    • Coordinated with other Quality System leaders for formal QSE rollout of new global Quality Systems
    • Prepared quality documents including procedures, SOP’s and work instructions for corporate and site validation efforts and activities.
    • Worked with Global Engineering on the development of the Installation, Commissioning and Qualification program (ICQ), developing the procedural documents for Requirements Specifications, Acceptance Testing, Installation Verification and Installation Qualification. Developed multi-site procedures and work instructions for Computer System Validation, Supplier Auditing and Risk Assessments in line with GAMP5 recommendations.
    • Worked with necessary stakeholders, including business process owners, site validation and quality, to ensure that methodologies to ensure new quality system met all GMP requirements and other quality standards.
  • Senior Training responsibility effort for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Provided support for Corporate Training Strategy and Organizational Effectiveness
    • Developed approaches and methodology for new global training projects.
    • Prepared and developed on-site and off-site training curriculum.
    • Managed the delivery of course materials through direct oversight of course creation, assessing stakeholder needs, tracking performance metrics and performing issue resolution.
    • Supported off-site communication of corporate training strategy to upper management and site level leaders
    • Reduced new employee on boarding time by developing and streamlining training programs to focus on customer value added requirements.
    • Created and optimized training curriculum; including instructional design of Instructor Lead and Computer Based Training.
    • Facilitated training curriculum including employee assessments.
    • Assisted with the creation of a new, more rigorous validation training program with an emphasis on GMP and validation procedures and application of validation concepts; thereby significantly improving the training metrics and validation activity success rate.
    • Supported global LIMS training implementation on time and budget
  • Senior Validation responsibility efforts for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Championed equipment qualification activities, i.e. Installation, Operation, and Performance qualification execution, deviation assessments and report development.
    • Provided technical support for the manufacture of cell-culture based live virus vaccines. This included equipment optimization, equipment qualification, and regulatory oversight.
    • Completed controlled temperature unit qualification activities; Installation and Operation qualification protocol development, execution, and report development.
    • 100% metrics accomplished; i.e. on time, within budget, and 0 deviations (RFT metrics).
    • Provided technical support for the manufacture of live virus vaccine: H1N1, amounting to approx. 42 million doses.
    • Participated in the design, coordination, and timely execution of multiple simultaneous validation studies for new and existing equipment for the manufacture and release of the H1N1 vaccine.
    • Prepared SOPs to govern operation and use of equipment to be qualified, protocols, and final reports for validation activities.
    • Provided technical support for the manufacture of live based virus vaccines. This cell-culture project included equipment optimization, equipment qualification, and regulatory oversight.
    • Revised manufacturing SOPs, batch records and related forms for content, accuracy and clarity. Reviewed SOPs, batch reports, Validation Master Plans, Final report packages and investigations for GXPs and content.
    • Performed activities related to PAI (Prior to Approval Inspection). This included assistance with FDA inspections.
    • Re-Qualification of -80°C freezer farm and -25°C warehouses and packaging line.
    • Qualification of new fill/finish suite.
    • Qualification of new QA lab, including lab instruments and equipment, i.e. Vitek, HPLC’s, benchtop autoclaves, dissolution systems, incubators and stability chambers.
  • Senior Validation responsibility efforts for a high-profile pharmaceutical, manufacturer of API products, including:
    • Led equipment qualification activities; Installation, Operation, and Performance qualification execution, deviation assessments and report development.
    • Prepared equipment Validation Master Plans.
    • Completed controlled temperature unit qualification activities; Installation, Operation, and Performance qualification protocol development, execution, and report development.
    • Qualification of new RO/DI water system.
    • Performed Steam Quality Testing.
    • Completed controlled temperature unit qualification activities; i.e. Installation, Operation, and Performance qualification protocol development, execution, and report development.
    • Autoclave qualification and validation
    • Validated new distribution system for fluid transfer of API Bulk product.
    • 100% metrics accomplished; i.e. on time and within budget.
  • Senior Validation responsibility effort for a high-profile packaging and distributor of food, beverages and OTC medications, including:
    • Designed, installed and trained staff on a new wireless temperature and humidly monitoring system for the distribution and packaging warehouses.
    • This wireless monitoring system was the first of its kind and implemented without interfering with the normal operation of the facility.
    • Authored SOPs detailing validation methods and procedures; created new SOPs and revised existing SOPs for purposes of clarity, content and necessary updates.
    • Led investigational efforts in determining root causes for atypical (temperature excursion) events and established corrective and preventative actions.

PROFESSIONAL EXPERIENCE

  • Reale Resources, LLC, President (Exton, PA) – 12/13 to Present
  • ECSquared, Inc., Owner/Director of Strategic Alliances (Wilmington, DE) – 10/07 to Present
  • Adcor Industries, Engineering Sales Manager (Baltimore, MD) – 10/06 to 10/07
  • Precision AirConvey, Regional Technical Sales Manager (Newark, DE) – 01/03 to 10/06
  • Peleg Diamond Company, Regional Sales Manager (Cleveland, OH/Tel Aviv, Israel) – 1/98 to 01/03

EDUCATION

  • Master of Science in Human Resource Management, Wilmington University, Wilmington, DE – 2005
  • Bachelor of Science in Marketing and Management, Davis and Elkins College, Elkins, WV – 1988

CERTIFICATION

  • Senior Professional in Human Resources (SPHR), HR Certification Institute, 2006
  • Graduate Gemologist (GG), Gemological Institute of America – 98 to Present

TRAINING

  • cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices, CfPIE
  • Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products, CfPIE
  • Process Validation for Drugs and Biologics, CfPIE
  • APOGEE Information Suite, Siemens
  • APOGEE with BACnet for Experienced Insight Users, Siemens
  • APOGEE Advanced Operations, Siemens