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