- 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.
Independent Contractor, 2000 - Present
- 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
- 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
- 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.
- 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
- 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"
- 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