SUMMARY

Regulatory Affairs and Quality Systems professional, experienced in FDA/ISO/ICH/MDD compliance for the development and marketing of medical devices (including IVDs), prescription and OTC drugs, biologics, and cosmetics. Areas of expertise include compliance with US and International regulations. Demonstrated skills in establishing: GMP and GCP auditing programs, employee training, design controls, CAPAs, document/change control, tracking and trending of complaints, and adverse event reporting, preparation for inspections by regulatory authorities, strategy for resolving 483s & Warning Letters. Regulatory submission experience includes initial filing and maintenance of IND, NDA, IDE, and 510(k) submissions.

PROFESSIONAL EXPERIENCE

REGULATORY LIAISONS, LLC – San Diego, CA 2002 – Present

Principal

Established company that provides customized regulatory affairs and quality system consulting services for developers, distributors, and manufacturers of medical products. Specific services include: · Preparation of regulatory submissions for investigational and marketed medical products

· Conducting GXP audits for compliance with US, EU, and Canadian regulations

· Presenting training sessions on topics such as:

General and targeted GXP training
Compliance expectations for executive management
Auditor training
How to manage an inspection by a regulatory body

· Identification, development, and implementation of quality systems including:

Auditing programs
Corrective and Preventive Action
Employee training
Document control and change control
Electronic document management systems (EDMS)
Customer complaint handling
Adverse event reporting

· Conducting due diligence audits as part of new project feasibility evaluations

SANTARUS, INC. – San Diego, CA 2001 – 2005

Senior Manager, Quality Assurance and Corporate Compliance 2004 - 2005

Manage internal and external GXP audits. Specific duties include: maintaining the audit schedules, providing agendas, conducting audit as lead auditor, writing audit reports, assessing adequacy of proposed responses from respondents and closing out observations
Develop Customer Complaint Handling systems for marketed drug product. Activities include:
defining user requirements, implementing, and maintaining customer complaints
authoring initial SOPs
overseeing the adequacy of the initial documentation
developing scripted responses frequently asked questions (FAQs)
managing call centers, and CROs assisting with medical information and adverse event reporting
speaking directly to customers to arrive at mutually agreeable solutions
developing process for retrieving drug product from field without violating wholesaler kickback laws
coordinating complaint investigations with CMOs
Presenting monthly updates on complaints and quality metrics

· Design, implement, and manage the corporate Training Program. Collaborate with IT to ensure the system compliance and successful validation. Interface with management throughout the company to ensure training requirements are defined and accomplished

· Develop a corrective and preventive action (CAPA) system. System goals are to ensure timely input, notification, and tracking of CAPAs, ensuring a closed loop to investigations, with the ability to track and trend findings and the investigations thereof

· Create training curriculum for and conduct initial employee and annual training in GMPs and GCPs.

· Generate monthly Quality Metric slide presentation for Senior Management

Senior Manager, Regulatory Operations 2003 - 2004

· Direct the compilation of CTD Module 1 for Santarus NDAs, with duties including: developing and managing project tasks and timelines, assigning review & approval authority, and finalizing documents into a format that can be submitted electronically to the FDA

· Manage e-publishing functions, including: template development, submission structure development, hyperlink naming conventions, timeline management, and ensuring timely delivery of documents to publishing personnel

· Assist in the development of Santarus’ CTD/NDA submission strategy

· Direct and assist internal staff, contractors and consultants as required, to ensure compliance with all US cGMP, GLP, and GCP requirements

· Manage employee training programs, with activities including: determining training requirements, developing a corporate training plan, developing GMP and GCP quality presentations, scheduling training, ensuring training is documented.

· Represent RA/QA for Product Launch Team

Manager, Regulatory Affairs and Quality Assurance 2001 - 2003

· Prepared and submitted initial IND applications, supplements, and annual reports for various drugs

· Supported QA activities including: master batch record development and review, final product release, non-conforming product investigations, corrective actions, training, and auditing

· Developed, implemented, and managed document control system

· Key member of the multidisciplinary team designated to determine a more permanent solution to overall electronic document control system (EDMS) and document control management. An additional goal of this project was evaluating less costly electronic document publishing tools to allow a start-up company to publish an electronic NDA

VICAL – San Diego, CA 2000 - 2001

Regulatory Affairs Associate

· Prepared and submitted biological master file to support the CMC section of various IND applications

· Assisted with the development of IND documentation

· Authored SOPs to ensure compliance

· Audited documentation for compliance with FDA regulations and NIH guidelines for Recombinant DNA

REGULATORY RESOURCES – Carlsbad, CA 2000

Senior Regulatory Consultant

· Established and supported FDA/ISO/MDD compliant quality systems for clients

· Conducted comprehensive quality system audits for medical device manufacturers, vendors, and distributors

· Reviewed labeling claims, including packaging and promotional materials for compliance

· Managed document control systems

· Managed post-marketing activities, such as adverse event reporting, and complaint management

BRAUN THERMOSCAN – San Diego, CA 1996 – 1999

Senior Regulatory Affairs Specialist 1999

· Prepared and submitted 510(k), followed up with FDA, with clearance being granted within 90 days

· Collaborated with Clinical Studies to formulate strategic plans for pre-market notifications

· Led team during external auditor site inspections

· Wrote procedures and work instructions for regulatory, quality, and customer service functions

· Supported international registrations and listing for Canada and CE-marked of products for the EU

· Conducted internal and subcontractor quality system audits, and ensured findings were effectively addressed through effective corrective and preventive action

· Developed and conducted annual and monthly QSR and ISO employee training

· Reviewed and approved change orders to ensure corporate compliance

Regulatory Affairs Specialist 1996 – 1999

· Managed customer complaint system (~6,000 calls monthly) to ensure regulatory compliance

· Tracked and trended complaint data to assist in determining potential need for corrective action

· Analyzed and presented data for periodic management reviews of the quality system

· Reviewed, analyzed, and submitted adverse event reports to regulatory agencies

· Conducted internal and subcontractor quality system audits

· Developed quality system and ISO training material and conducted training sessions

APPLIED BIOTECH, INC. – San Diego, CA 1993 - 1996

Quality Assurance/Quality Control Supervisor 1993 – 1996

· Developed and maintained QA/QC systems and procedures including: production master files, device history records, SOPs, QC specifications, rework records, variances, and rejected material reports

· Developed and managed customer complaint and label copy approval systems

· Assisted with the collection of clinical trial data, writing, and filing of 510(k)s

· Conducted GMP audits; ensured adequacy of CAPAs

· Prepared and conducted corporate Safety and GMP training

· Supervised and trained QC Chemists in the inspection of medical diagnostic devices (IVDs)

· Oversaw inspection and disposition of incoming raw materials

Quality Control Chemist 1993

· Performed physical and functional inspections on in vitro diagnostic devices manufactured on-site

· Documented, organized and maintained retention samples to be used for subsequent stability studies

MYCOGEN CORPORATION – San Diego, CA 1990 – 1993

Research Assistant

· Designed and conducted experiments optimizing the growth and preservation of bacteria and fungi via cryoprotection and lyophilization

· Prepared, grew, and processed biological fermentation batches of inoculum. Performed quality control assessments including bioassays of inoculum used in field trials

PREVIOUS WORK / RESEARCH EXPERIENCE

UCLA 1988 – 1990

Academic Tutor

· Coordinated and conducted weekly sessions and assisted students with time management techniques

Undergraduate Researcher

· Designed and carried out experiments using animal models of schizophrenia

· Analyzed data using standard statistical techniques, and reported results in honors thesis

PROFESSIONAL CERTIFICATIONS

· Regulatory Affairs Certified (US RAC) through the Regulatory Affairs Professional Society, 1998 - Present

· Quality Management Professional Certificate, University of California at San Diego, 1995 – 1997

· Customer Service Specialist Certificate, University of California at San Diego, 1996 – 1997

PROFESSIONAL AFFILIATIONS

· Adjunct Faculty, San Diego State University and Thesis Committee Member

· Committee member for establishing and maintaining the SDRAN Mentoring Program 2009 - Present

· Vice President of Programs, San Diego Regulatory Affairs Network (SDRAN), co-chair; 2006 – 2008· Member of RAPS, OCRA, and San Diego Regulatory Affairs Network( SDRAN)

INSTRUCTOR FOR SDSU MASTERS of SCIENCE in REGULATORY AFFAIRS & UCSD EXTENSION COURSES

2001 – Present

Lead Instructor or Instructional Facilitator UCSD Extension courses and graduate level courses at San Diego State University (SDSU) for the following courses: courses including:

· An Overview of FDA Regulations for Medical Device Professionals; UCSD Extension

· Good Manufacturing Practices; UCSD Extension

· RA 601, Pharmaceutical, Biotechnologies, and Medical Device Industries; SDSU

· RA 602, Introduction to Food and Drug Law; SDSU

· RA 770, Current Good Manufacturing Practices, General Concepts; SDSU

· RA 771, Current Good Manufacturing Practices, Advanced Topics; SDSU

· RA 774, Investigational & Marketing Applications for Drugs, Biologics & Medical Devices; SDSU

· RA 783, Effective Communication for Healthcare Professionals

PRESENTATIONS

· Guest Lecturer for Regulatory Courses, San Marcos State University, September 2010

· The Impact of Poor Writing in Regulatory and Quality, SDRAN presentation, August 2010

· Regulatory Affairs Overview, UCSD Sponsored Med Chem Conference, March 2010 & 2011

· Various presentations for SDRAN in support of the US RAC Exam Study Group, 2008 - present

PUBLICATIONS

· Guy, L, and Godfredsen, K. September 2002. RAPS Focus Magazine, “Regulatory Academic Programs: Deciding to Participate and Selecting a Quality Program,” Regulatory Affairs Focus, pp 10–12.

· Gundersen, L and Guy, L. April 2002, IVD Technologies, “Academic Training for Regulatory Professionals.” Volume 8, Number 3, pp 22-24.

· Guy, L. May 2001. How the FDA and the NIH Interact Regarding the Regulation of Gene Therapy. Culmination Project for the Masters of Science in Regulatory Affairs Program at SDSU.

· Guy, L. November 2001, RAPS Focus Magazine, “Gene Therapy Oversight: Who’s Peering down the Microscope?” pp 6-10.

EDUCATION

Masters of Science, Regulatory Affairs, San Diego State University

Spring 2001, GPA 3.93

Bachelors of Science, Psychobiology/ Neuropharmacology, UCLA

College Honors, Honors in Psychology, Cum Laude