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

Technical Consultant #1824


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
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