- 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.
- 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).
Supplier 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.
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.
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.
- 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"
- MBA Business Finance, Rushmore University
- B.S. Biology and Chemistry, Warren Wilson College