Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA Zenaida Power Regulatory Expertise:

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1 Regulatory Expertise: Pharmaceuticals: Sterile-Liquids, Non-Sterile Liquids, Solid Oral Dosage Form, Parenterals, Antibiotics, APIs/Bulk Chemicals, Creams & Ointments Medical Devices: Implantable / Active Implantable, Durable, IVDs, Software Medical Imaging, Medical Instruments, Infusion devices, Stents Biologics: Biotech, Monoclonal Antibodies, Vaccines Others: Blood Banking, Combination Products and Nutraceuticals Capabilities: Audits and Gap Analysis; 21 CFR 210/211, 820, 600, QSIT, GXP, ISO 9001/13485/14971/17025/10993/14644/60812/61025 FDA inspection support and Form 483 and Warning Letter Responses Expertise with Medical Device Directive (MDD), Medicines Control Agency, Health Canada (HPFBI) and Mexican Health Authority and support during these inspections Development and Implementation of Quality System Programs Development of Investigation Programs and independent analysis and resolution of investigations; deviations, manufacturing and nonconforming products, customer complaints, OOS and OOT. Adverse Event Evaluation and FDA Reporting Recall Management Due diligence Reports Personnel Training Technical Expertise: Aseptic Processing, Media Runs, Batch Record Review, Drug Chemistry, Clean Rooms-Qualification, Clean-In-Place (CIP), CMC Review, Commissioning, Corrective and Preventive Action (CAPA), Design Controls, Document Controls, Manufacturing and Process Engineering, Environmental Monitoring, Facility Operations and Maintenance, Factory Acceptance Testing (FAT), Failure Investigations, Laboratory Controls, Lyophilization, Metrology/Calibration, Microbiology, Out-of-Specification (OOS) Investigations, Packaging and Labeling, Preventive Maintenance, Project Management, Quality Engineering, Root Cause Analysis, Development Quality Programs, Stability Programs, Statistical Process Control (SPC), SOP Development, Sterile Packaging, Aseptic Sterilization, Dry Heat Sterilization, ETO Sterilization, Gamma Sterilization, Steam Sterilization, Technical Writing, Cleaning Validation, Computer Control System Validation, Equipment Validation, Facility Validation, Process Validation, Retrospective Validation, Utility Validation, Validation Master Plans, WFI, High Purity Water Systems Submissions Review DMF, 510(k), BLA, CMC, Combination Products, ELA, PLA, IDE, IND, NDA, ANDA, PMA Clinical Expertise: GCP Audits, FDA inspection support and 483 responses, initiation visits, Manage - sites, study, protocol deviations Languages: English, Spanish Page 1

2 Employment History: Dec. 99 to Present: Technical and Regulatory CGMP Compliance Consultant to the Biotechnology, Pharmaceutical, Medical Device, Biologics, Repackagers and Nutraceuticals Industries Work with clients in the pharmaceutical, medical device, biologic, biotechnology and Nutraceuticals industries to develop quality assurance and regulatory strategies for compliance with FDA regulations by: Conducting gap assessments of client policies, procedures, programs and studies, to determine compliance to regulatory requirements. Assisting with development and implementation of quality systems policies, procedures and validation programs that meet regulatory requirements. Developing and implementing corrective action plans to address deficiencies. Presenting GMP/QSR training. Performing investigations of deviations, nonconforming products, customer complaints, OOS and OOTs. Developing CAPA strategies. Performing evaluations of complaints to determine reportability as per 21 Code of Federal Regulations. Reporting complaints to FDA authorities, as needed. Implementing vendor audit programs, quality agreements and performing vendor audits Developing and publishing Product Annual Reports Representative consulting long term projects have included: Establishing Quality Programs for eight (8 separate projects) pharmaceutical companies including a combined product (pharmaceutical in a device); preparation and implementation of QA/QC documentation, policies, and procedures, Master Batch Record preparation and new standard operating procedure (SOP) preparation, Batch Record data review and approval, routine GMP compliance, including establishment of Vendor Audit Programs, Internal Audit Programs, performing supplier/vendor/lab audits, performing internal audits, assuring corrective action implementation and closure, and review of validation documentation. Additionally, Assisted a biopharmaceutical company in preparing for a pre-approval inspection of an NDA, and responding to FDA 483 observations. This resulted in recommendation of approval of the drug. Reviewing product specifications (one pharmaceutical manufacturer) to ensure compliance with current USP, JP, and EU testing requirements for a pharmaceutical company. Assisting a biotechnology company in preparing for Phase III clinical studies of a new drug application (NDA). Acting as GMP Quality Manager for two (2) southern California biotechnology companies; establishing and implementing Quality Programs. Supporting three (3) pharmaceutical companies in their vendor qualification programs; performing audits of pharmaceutical, device companies and product distributors to assure compliance with CGMP regulations for finished pharmaceuticals, biologics, and Quality System Regulation (QSR). Assisting an API manufacturer in preparing for pre-approval inspection (PAI) of a new API application. Developing all required documents in compliance with CGMPs and ICH Q7A. Providing company wide PAI and CGMPs Training for a Biotechnology virtual company. Page 2

3 Medical Device related projects have included supporting medical device companies in their Quality Enhancement Projects including the design and implementation of sustainable Quality System Programs in defined sub-systems; Design Controls / Risk Management, CAPA, Change Controls, Material Controls, Complaints, MDRs, Product Field Actions, Purchasing Controls/Supplier Management, Internal Audits and Training. Developed As Is and To Be process maps, assessed gaps and underlying root causes, defined, developed, and implemented team-specific corrective actions with defined deliverables, developed and executed system improvements, integrated, and linked other related systems to ensure robust quality systems and implemented corrective actions. Included Preparation for inspection and re-inspections. Representative companies have included; a) manufacturer of infusion medical devices and needle-free IV sets and accessories b) manufacturer of implantable medical devices for the spine, knees and hips c) manufacturer of medical Imaging medical devices; CAPA, Complaints investigation and implementation of a sustainable training program d) manufacturer of instruments, implantable and thoracolumbar devices. Project Management and development of QS included multiple facilities in various countries (US, France and Switzerland). e) manufacturer of Iontophoresis / transdermal drug delivery devices; prepared a gap assessment, developed a Quality Improvement Plan and Risk Management Plan, provided support during an FDA inspection as well as support in their risk management implementation plan and validation efforts. f) manufacturer of implantable dental medical devices; performed a gap assessment prior to their first FDA inspection, provided FDA Inspection support, developed QS, personnel Training and FDA Inspection Preparedness. Prepared and published the response to the FORM 483 to FDA. g) two (2) separate projects for manufacturers of Carotid Artery Stent and Monorail Delivery Systems; 1) implemented a CAPA process, performed evaluations/ investigations and implemented required upgrades. 2) Performed a Chemistry Laboratory audit/published report of deficiencies and implemented a laboratory OOS/OOT and laboratory equipment validations programs GensiaSicor Pharmaceuticals, Inc. Manager, CGMP Compliance and Professional Services Manager Responsibilities included; Managing the company s compliance program to FDA regulations, foreign regulatory agencies, such as the British Medicines Control Agency and the Mexican Health Authorities, and responding to regulatory agencies observations. As a result; coordinated, managed, and participated in six (6) FDA pre-approval and post-approval inspections by CDER for ANDA submissions, and one CBER preapproval inspection for an NDA submission. Also coordinated, managed, and participated in one FDA facility inspection to assure compliance to CGMPs as part of the facility changes to the manufacturing plant #I and one pre-approval inspection by the British Medicines Control Agency for an NDA submission, and one inspection by the Mexican Health Authority for the pre-approval of one product to be sold in the Mexican market. Managing the Complaint Investigations Programs; evaluating, investigating, tracking and reporting, of customer complaints and correspondence with complainant, and/or FDA, when applicable (AE Reporting), Tracking and Trending and annual reporting. Managing the Internal Audit Program, including laboratories and manufacturing areas to assure compliance with federal and company regulations as well as company s contract manufacturing (clients) requirements. Managing the Vendor Audit Program; auditing foreign and domestic suppliers/vendors of active pharmaceutical ingredients, excipient, component vendors, and contract laboratories. Tracking and trending audit responses for vendor audits as well as internal audits Page 3

4 Assisting in company wide GMP Training and Pre-approval Inspection (PAI) training programs. Participating as the Company Safety Liaison/Coordinator. Designing quality documents and records; new and updated SOPs and protocols to ensure current requirements; including but not limited to vendor qualification programs and Quality Agreements, Risk Management, Change Control, Deviations / CAPA, Incoming and Finished Product Inspections, Batch Records, Product Annual Reports, Validation Master Plans, etc. Reviewing necessary data for product submissions. Proofing and approving all package labeling, including new labeling and diagrams for new ANDA submissions. Participated in two Project Improvements Analyzed nonconformance and development of a strategic plan for decreasing non-conformances by 50% in 1996 from the previous year, and the goal was met. Conducted labeling assessments, and developed an improved labeling approval process and label specifications Bio-Rad Laboratories, Anaheim, CA Senior Chemist Senior Technical Representative Responsibilities included: Overseeing product development; manufacturing formula and testing requirements, overseeing all aspects of production of the company's In Vitro Devices in accordance with federal regulations/cgmps and GLPs, company policies/specifications, and ISO 9001 and Supervised technicians during the production phase. Overseeing the scaled-up/technology transfer of new products from R&D to production. Reviewing finished product testing results/ensuring compliance to established specifications. Developing the product (clinical controls) literature and labeling; Interfacing with customers in clinical laboratories. Serving as a companywide auditor for compliance with GMP and ISO 9001 regulations. Coordinating document control for writing new and updating all departmental procedures for company ISO 9001 certification. Designing, writing, and reviewing necessary data for product submissions (510K) to FDA. Developing tracking reports and product history files. Translating technical reports into Spanish for Latin American and European markets. Estimating labor and material requirements for manufacturing of each product Independent Consultant Responsibilities included: Assisting in the design, writing, and review of more than five clinical research protocols for IND and NDA submissions for two pharmaceutical. Auditing/Reviewing Informed Consent Forms for accuracy and compliance with federal regulations for four major clinical studies. Auditing/Reviewing and processing Case Report Forms Johnson & Johnson, Ortho Diagnostics, Inc, Raritan, NJ Group Leader/Serologist Responsibilities included: supervising nine Technicians and Serologists, scheduling daily work, reviewing, verifying, and approving test results, testing raw materials, human whole blood, plasma, and serum to Page 4

5 determine suitability for use in the production of diagnostic agents, training new laboratory personnel and developing new procedures or updating written procedures to current practices. PROFESSIONAL AFFILIATIONS: Parenteral Drug Association (PDA), Orange County Regulatory Affairs (OCRA) Association of Analytical Communities (AOAC) National Nutritional Foods Association (NNFA) AWARDS: 1997 Process Improvement Award, GensiaSicor Pharmaceuticals, Inc. EDUCATION: Graduate Studies in Biological Sciences and Medical Technology, School of Medicine of N.J. and Fairleigh Dickinson University, Rutherford, NJ 1974 B.S. in Biology, Minor in Spanish, Jersey City State College, Jersey City, NJ Page 5