Pharmaceutical, Medical Device and Human Tissue Quality Auditor and Compliance Consultant

Expertise

Quality System

• Supplier quality system audits, supplier qualification, SCAR management and non-conforming material control and disposition.
• Quality system design: Medical device per QSR (21CFR PART 820) and ISO13485 requirements; and pharmaceutical per 21CFR 210.
• Designing Quality systems per 21CFR part 1271 (tissue and cellular therapy).
• Writing and reviewing Standard Operating procedures, SOPs and Work Instructions.
• Perform quality system audits per 21CFR 820 cGMPs (medical device), 221 cGMPs (pharmaceuticals), 600 cGMPs (biomedical), and 21CFR 1271 cGTPs (tissue and cellular therapy) and ISO 13485.
• IQA: Establish incoming inspection criteria, and First Article (FA) requirements.
• cGMP training: Train personnel on cGMP and cGLP principles and practices.
• Process optimization: Design of experiments (DOE) and statistical process control.
• Part 11 implementation: Electronic signature and the audit trail.

CAPA and Compliant System Management

• CAPA system design.
• Managing a customer complaint system.
• Managing a CAPA system.
• Leading CAPA closure activities.
• Performing root-cause analysis.
• Remediation project management.

Change Control System

• Product development validation, verification, change control, and product transfer activities.
• Designing a supplier change control system.
• Performing stakeholder analysis.
• Perform risk assessment through PFMEA, and DFMEA.

Process Validation Performance

• Cleaning validation (CIP and out of place).
• Laboratory test method validation.
• E-beam sterilization.
• Ethylene oxide sterilization.
• Steam sterilization (autoclave).
• Sterad (hydrogen peroxide based) sterilization.
• Process test method validation.
• Shelf life validation.
• Writing DQ, IQ, OQ, and PQ protocols.
• Automated (computerized) systems validation.
• Packaging validation.
• Performing new facility commissioning.
• Test method validation (Analytical and physical).

Supply Chain and Quality Management

• Managing Supplier Corrective Action (SCAR) systems.
• Qualifying suppliers.
• Supply agreements author.
• Supplier performance matrix author.
• SCAR system design.
• Supplier auditor.
• Supplier performance evaluation.
• CMO Quality Risk Management(QRM).
• Supplier pipeline Management for CMOs.
• Supplier Quality Agreements: Writing, implementation, enforcement and monitoring of contracts.
• Supplier selection and qualification.
• Development of supplier performance matrix.
• Performing supplier Quality Audits:ISO13485,ISO9001,21CFR820.00 and 21CFR 210 and 211.

Regulatory and Compliance

• Implementation of 21CFR part 211 and 210 for pharma.
• Implementation of the QSR 21 CFR 820.00 for medical Devices.
• Implementation of 21CFR 600s for biologics.
• Implementation of 21 CFR part 1271 for Tissue.
• 483 Resolution.
• Consent decree resolution.
• Warning letter resolution.
• CMC Biosimilar requirement development.

Experience

Independent Contractor, 2000 - Present

Projects

• St Jude Medical, Orange County, CA: Process validation compliance remediation.
• BD Diagnostics, Atlanta, GA: New facility commissioning and Process validation.
• Zimmer Orthopedic, Warsaw, IN: Cleaning validation: Automated processes.
• St Jude Medical, Plano, TX: Process validation: ETO sterilization.
• Ethicon: Johnson and Johnson, Cincinnati, OH, New Product transfer (capital equipment manufacturing).
• Davol Medical, Warwick, RI: Beam sterilization.
• Abbott Labs, Redwood City, CA: Process Validation.
• Boston Scientific, Maquet, San Jose, CA: New product and process validation.
• Boston scientific, Valencia, CA: Senior Process Validation Engineer to draft a master validation plan for the project.
• Applied biosystems, Redwood city, CA: Supplier Quality Manager.
• Johnson & Johnson, (Advanced Sterilization Products), Irvine, CA, Project: supplier quality management.
• Peak Surgical, Palo Alto, CA, Quality system Design and validation.
• Genetech, San Francisco, CA, CIP Cleaning Validation.
• Tissue Banks International, San Rafael, CA: Tissue and cellular therapy - steam validation (autoclave).
• American Red Cross, Biomedical Service, Washington, D.C: Blood banking, CAPA system and change control.
• Pfizer, NY,NY Process Engineering: Equipment Qualification and warning letter remediation
• Nexgen Pharma, Irvine, CA : Equipment Qualification, Process Validation and warning letter resolution

Engineering Projects

• Process Validation: Packaging, Serialization, Stability/Transit processes, packaging (Serialized and non-serialized products and cleaning validation.
• Equipment Qualification: Blenders, Ovens, Mills, Tablet Presses, Film Coaters, Laboratory equipment, Ovens, Autoclaves, stability chambers, Fillers, and Lyophilisors.
• New facility commissioning: Pharmaceutical, medical device and Tissue.
• USP Water system validation: Purification, Storage and distribution.
• Process Failure mode and Effect
• Analysis: PFMEA,FAT and HAZOP.
• Equipment Design Mode and Effect Analysis: DFMEA.
• Medical device Design control.
• Facility and Facilities commissioning.
• Test method validation.
• New facility and equipment commissioning: Clean room validation, HVAC, chemical reactors, Nitrogen systems, and water purification systems.

Services Provided for Projects

• Gap assessment for regulatory compliance and remediation.
• Identify key processes, write and design validation master plan.
• Write protocols for qualification and validation of identified processes.
• Identify testing and verification methods required for process outputs.
• Write test method validation protocols.
• Write in-process inspection procedures and acceptance criteria.
• Write process performance qualification protocols.
• Facility commissioning activities.
• Equipment qualification activities, (DQ ,IQ, OQ, PQ).
• Process design and validation activities and validation reporting.
• Validate water the purification system.
• Clean-room validation and test method validation.
• Change control activities.
• Design of Experiment (DOE) activities.
• Review and approve protocols.
• Validation team lead: track tasks and maintain schedules.
• Gap analysis per ISO 11135:2008 and ISO 111727.
• New product transfer activities.
• Product qualification and component qualification activities.
• Define material acceptance activities.
• Root-cause analysis.
• Design sampling plans and test methods for IQA.
• Sterilization gap analysis.
• Implement best solutions.
• Perform dose mapping.
• Determine correct SAL levels.
• Material qualification.
• Qualify new production equipment.
• Write software validation protocols.
• Facility commissioning and HVAC validation activities.
• Manage validation schedules, and budget.
• Packaging, shelf life and transit validation.
• Qualify wet chemistry equipment.
• Validate wet processes.
• Review and improve supplier corrective action request system.
• Implement supplier audit system.
• Resolve CAPA issues in the consent decree issued by the FDA.
• Design CAPA and change control systems.
• Write CAPA Work Instructions, and SOPs.
• Implement a centralized change control system.

Honors & Publications

Credentials

• Certified Quality Engineer.
• Certified DOE instructor.
• Certified change control and CAPA and GMP Instructor.
• Certified Quality System Auditor.
• Certificate of Achievement: Course work in group dynamics and managing organizational change, and Process improvement, NTL Institute.
• Chemical Engineering: System dynamics, fluid mechanics, water purification methods, thermodynamics, plasma physics, and nuclear physics, University of New Mexico.
• Co-Founder and CEO, CGMP University Inc.

Software

• Minitab - Statistics
• ASQc Tab - Statistics
• MS project - Project management
• AUTOCAD - Drawings
• CATS Web - Change control, NCRs and EO process
• Documentum - Document controls
• SAP - Inventory and material management.
• E-Pro - Packaging
• MS Visio - Process mapping
• MS word - Document creation

Publications

• Designing CAPA systems and Quality Systems for FDA Regulated Industries
• "Change Control for FDA Regulated Industries"
• "Principles of Process Validation"
• "How to Perform Process Validation"

Education

• M.B.A. Pharmaceutical Marketing, St Joseph University, Philadelphia, PA
• Ph.D. (Candidate), Business, North Central University, Minneapolis, MN
• M.S. Chemical Engineering, American InterContinental University (AIU), Dunwoody, Georgia
• M.S. Chemical Engineering, Heriot Watt, Galashiels, United Kingdom
• B.S. Biology - Chemistry, Warren Wilson College, Swannanoa, NC