Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA Terri Dodds CAPT. (RET) TERRI L.

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1 SKILLS/SPECIAL QUALIFICATIONS: Regulatory Expertise: Technical Expertise: CAPT. (RET) TERRI L. DODDS - BSN, RN Former Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Biologics and Bioresearch Monitoring, holding the positions of Investigator, Drug Pre-Approval Manager Supervisory Investigator, Foreign Inspection Cadre Member. Extensive knowledge of pre- and post-market FDA regulations/requirements for pharmaceutical and biologic products. Conducted over 200 global pharmaceutical inspections, including drug pre-approvals. Conducted quality system audits to assess compliance with current Good Manufacturing Practices (cgmps). Fully certified in all areas of Pharmaceutical Inspectorate training, including: Regulating Pharmaceutical Quality and the Relationship to FDA's Mission; Risk Management; Advanced Quality Systems; Pharmaceutical Science; Process Analytical Technology, Current Regulatory Programs and Procedures; Technology; and Investigational modules. Experienced in effectively interpreting and resolving FDA-483/Inspectional Observations, Warning Letters, and other Agency-issued compliance documents. Effective presenter and trainer, having conducted numerous presentations at FDA and industry conferences/training sessions. Biologics: Allergenics, Biotech, Monoclonal Antibodies, Tissue, Vaccines Pharmaceuticals: Antibiotics, APIs, Creams & Ointments, Non-Sterile Liquids, Suspensions, Transdermals, Powders, Solid Oral Dosage Form, Parenterals, Aerosol Dispensed Medications Adverse Event Evaluation, Certification Audit, Due Diligence Audit, GCP Audit, GLP Audit (Animal), GMP Audit (Biologics), GMP Audit (Pharmaceuticals), FDA, Form 483 Responses, Warning Letter Responses, Consent Decree Responses, Hazard Analysis, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/Implementation, Regulatory Affairs, Regulatory Strategy Consulting, Training Aseptic Processing, Batch Record Review, Clean Rooms-Design & Qualification, Clean-In-Place (CIP), CMC Review, Commissioning, Corrective & Preventive Action (CAPA), Document Controls, Equipment Qualification, Environmental Monitoring, Facility Operations & Maintenance, Failure Investigations, Fermentation, Lyophilization, Metrology/Calibration, Out-of- Specification (OOS) Investigations, Packaging & Labeling, Preventive Maintenance, Process Optimization, FMEA/FMECA Risk Analysis, Gap Analysis, Risk Analysis, Root Cause Analysis, Stability Programs, Statistical Process Control (SPC), SOP Development, Sterile Packaging, Aseptic Sterilization, Dry Heat Sterilization, Gamma Sterilization, Steam Sterilization, Terminal Sterilization, Cleaning Validation, Equipment Qualification, Facility Commissioning,, Process Validation, Retrospective Validation, Validation Master Plans, WFI, High Purity Water Systems Page 1

2 Clinical Expertise: WORK EXPERIENCE: Institutional Review Board (IRB)-Submission, Approval, Close Out Manage-Monitoring Visits, Patient Eligibility, Protocol Deviations Reports-Site Visits, Study Reports, Annual Reports, Review and Interpret Pertinent Clinical Data, Serious Adverse Event Reporting, Source Documentation Development, Study Drug Preparation 2006-Present Jeff Yuen & Associates, Inc. Consultant Works with clients in the pharmaceutical, bioresearch and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations by: Conducting assessments of client studies, procedures, and programs to determine compliance. Assisting with development and implementation of quality systems, and validation programs. Developing and implementing corrective action plans to address deficiencies. Presenting pharmaceutical GMP training. Conducting mock inspections to familiarize clients with FDA inspection process. Direct experience in conducting cgmp audits, mock inspections, and due diligence audits of pharmaceutical manufacturers (all dosage forms), Active Pharmaceutical Ingredient (API) manufacturers, sterile drug manufacturers, control laboratories, and biopharmaceutical based companies. Perform systematic and independent examinations of functional areas, systems, and documents to determine whether business practices meet company policies and procedures, FDA s cgmp requirements, and Q7A requirements. Develop custom audit reports detailing the audit scope, significant findings/nonconformances, assessment of the regulatory risk posed by the findings, and recommendations for corrective actions. Based on audit findings, design and implement appropriate corrective actions, taking into account regulatory significance as well as best business practices U.S. Food and Drug Administration, Seattle District Office Pharmaceutical Inspectorate/Investigator Participated in and received full certification as a Level III Pharmaceutical Inspectorate (PI) Investigator. Certification included a rigorous selection process, an extensive two year program of classroom training given by FDA and Industry, and a four week detail in the Center for Drug Evaluation and Research (CDER) and the Center of Veterinary Medicine (CVM). Certification also involved interviews with CDER PI Committee members, as well as independently conducting an in-depth, systematic drug facility inspection while being audited by an Agency National Drug Expert. Relied upon to conduct the most complex drug inspections. Viewed as the key District resource in developing evidence to support regulatory decisions and actions as related to pharmaceutical and drug inspections. Provided training to investigators, chemists, and other District staff in the areas of pharmaceutical GMPs. As a Foreign Cadre member, conducted numerous international Pre-Approval and GMP inspections. Page 2

3 U.S. Food and Drug Administration, Los Angeles District Office Supervisory Consumer Safety Officer Drug Pre-Approval Group Supervisor Managed the inspectional activity of the drug-approval group, covering 400 drug manufacturers of sterile drugs, tablets, capsules, aerosols, transdermals, active pharmaceutical ingredients, medical gases, and veterinary drugs. Managed several Program Segments, (e.g. Drugs, Drug Pre- Approvals, Medical Devices, Veterinary Drugs, and Foods) performing technical and investigative work covering Southern California and Arizona. Planned, organized, and prioritized pre-approval assignments, and directed the assignments to completion. Active in decision-making process for compliance recommendations involving New Drug Applications. Provided direct guidance to the Center for Drug Evaluation and Research (CDER) Pre-Approval Branch Chief; made recommendations which influenced Center approval decisions. Conducted foreign and domestic drug pre-approval inspections, including manufacturers of drug substances (chemical synthesis, fermentation, peptides, and extractions), finished drug products (tablets, sterile manufacturing, capsules, aerosols, and transdermals), and control laboratories (microbiological and chemical). Prepared lectures to the pharmaceutical/medical device industry on regulatory subjects, to include preparing for an FDA inspection, Agency trends, violations, and recommendations. Focal point for educational training and guidance activities involving pre-approval policies and programs targeted to industry and government officials, public organizations, and technical publications. Provided educational training and guidance activities involving pre-approval policies and programs targeted to industry and government officials. District Trainer for New Hire Training Program within Los Angeles District. Developed and presented information to investigators on inspectional techniques, Drug Pre-Approval and Good Manufacturing Practices inspections, evaluating inspectional findings, and effectively documenting these findings in establishment inspectional reports (EIRs). Established guidelines and performance expectations for staff. Planned, assigned, reviewed, and evaluated subordinates' work products. Communicated with a wide spectrum of individuals, such as directors, compliance officers, junior and senior investigators, microbiologists, chemists, and supervisors U.S. Food and Drug Administration, Denver District Office Consumer Safety Officer District's Primary Drug Specialist. Conducted complex inspections (GMPs, Pre-Approval, and APIs) of domestic and foreign drug manufacturers. Recommended new drug approval, withhold or regulatory action based on inspectional findings. Conducted joint drug inspections with National Experts, Analysts, Microbiologists and CDER personnel. Provided specialized training to investigators in the areas of Drugs and Bioresearch Monitoring. Effectively managed and supported team during Supervisory absence, including the supervision of 11 subordinates U.S. Food and Drug Administration, Los Angeles District Office/Irvine Resident Post Consumer Safety Officer Conducted complex inspections of drug, bioresearch monitoring, and blood bank companies, focusing in GMP and Pre-Approval inspections. Page 3

4 Conducted independent investigations of consumer complaints and tampering, including the review and collection of pertinent records and samples; conducted joint inspections with CDER personnel. Developed evidence for regulatory purposes. Prepared concise, factual reports on investigations and special assignments frequently used in regulatory actions. Collected samples and conducted field examinations. Performed as Acting Supervisor in Supervisor's absence, which included supervising ten investigators and two secretaries. Provided training to investigators in the areas of drugs, biologics, and bioresearch monitoring U.S. Army Nurse Corps - Fitzsimmons Army Medical Center, Denver, CO Surgical Intensive Care Staff Nurse Supervised a staff of two paraprofessional and four professional personnel as Charge Nurse. Provided holistic and comprehensive nursing care to critically ill surgical intensive care and post anesthesia patients in a 13-bed surgical intensive care unit at a major Army Medical Center. Planned, coordinated, managed and evaluated nursing care in accordance with current professional nursing standards and departmental goals. Managed, supervised and trained 20 assigned staff as the Interim Head Nurse in the incumbent's absence. As a patient/family advocate, maintained open, effective communication and negotiated with the multifaceted health care system; as a preceptor for critical care nurses, practical nurses and reserve personnel, assisted in guiding and training them U.S. Army Nurse Corps - General Hospital, Frankfurt, Germany Assistant Head Nurse Planned, coordinated, supervised and directed the care rendered to patients on any given shift in the emergency room setting. Supervised 4-6 professional and paraprofessional nursing staff on all shifts; planned and coordinated the scheduling of employees. In-service Coordinator, trained hospital staff by providing continuing education in-services U.S. Army Nurse Corps - Army Intensive Care Nursing Course, Fort Sam Houston, TX Student Completed an intensive care nursing course designed to allow the professional nurse to render comprehensive critical care to all types of patients from neonatals to adults. Studied and applied nursing and scientific principles in the intensive care setting. Researched various intensive care methods and situations. Attended classes and seminars to increase knowledge base in the areas of critical care nursing U.S. Army Nurse Corps - Brooke Army Medical Center, Fort Sam Houston, TX Assistant Head Nurse Planned, coordinated, supervised and directed the nursing care delivered in the Coronary Care Unit. Instructed CPR classes for unit and hospital staff. Created, prepared and implemented care plans specific to coronary care. Supervised, managed and evaluated 6-8 nursing personnel in the delivery of patient care. Page 4

5 RELEVANT FDA TRAINING: 2006 Pharmaceutical Inspectorate Detail (4-week CDER assignment) Pharmaceutical Analytical Technology (PAT cadre) 2005 Pharmaceutical Inspectorate Training 2003 Quality System Inspections Basic Medical Devices Level II Drug Investigator Auditor Training 2001 Active Pharmaceutical Ingredients Training 2000 Compliance Training Scale-Up and Post-Approval Changes (SUPAC) Forum 1999 Training on 21 CFR Part 11, Electronic Records/Electronic Signatures Computer Systems Validation Course 1998 Quality Systems and Auditing Medical Gas Workshop Advanced Clinical Bioresearch Monitoring and Bioequivalence 1997 Radiopharmaceuticals Microbiological Aspects Industrial Sterilization for Drugs and Medical Devices 1996 Pre-Approval Inspection Course 1995 Statistical Process Improvement Technique for Process Validation 1994 Meeting with Industry: Pre-Approval Inspection Process FDA Conference on Sterilization/Process Validation Los Angeles District Pre-Approval Training FDA Conference: Inspections of Drug Firms (Aseptic Fill, Terminal Sterility and Validation) 1992 Introductory Course to Pharmaceutical Manufacturing Basic Food and Drug Law & Evidence Development Training Drug Manufacturing Quality Control 1991 Pharmacology and Experimental Design Introduction to Bioresearch Monitoring Introduction to Pharmaceutical Manufacturing AWARDS AND HONORS: PRESENTATIONS: Recipient of over a dozen Public Health Service (PHS) commendations and Food and Drug Administration (FDA) awards in recognition of superior work and performance, including but not limited to: three (3) PHS Unit Commendation Medals; three (3) PHS Achievement Medals; three (3) PHS Achievement medals; and a PHS Bicentennial Unit Commendation FDA Pharmaceutical Inspections - presented to University of Washington Pharmacy students 2002 Drug Inspection Quality System - hosted by the Orange County Regulatory Affairs (OCRA) Cleaning Validation - hosted by Orange County Regulatory Affairs (OCRA) 2001 FDA Drug Pre-Approval Requirements - hosted by International Society of Professional Engineers (ISPE) FDA Inspections: Compliance with US Regulatory Requirements - hosted by Regulatory Affairs Professional Society (RAPS) 2000 Current Pre-Approval Inspection Compliance Concern and Issues - hosted by Parenteral Drug Association (PDA) Recalls and Market Withdrawals - hosted by Orange County Regulatory Affairs (OCRA) FDA's Inspection Management - hosted by Regulatory Affairs Professional Society (RAPS) 1999 FDA Inspection Highlights - hosted by Regulatory Affairs Professional Society (RAPS) Page 5

6 EDUCATION: 1990 M.A. in Business, Webster University; Aurora, CO 1983 B.S. in Nursing, Mt. Marty College; Yankton, SD 1980 B.S. in Education/Minor in Biology, University of Nebraska; Lincoln, NE Page 6

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