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SANDRA K. GARRIDO
(469) 656-1280 (Home)
(972) 757-8322 (Mobile)
HYPERLINK "mailto:[email protected]"
General:
Rich diversified background that includes U.S. FDA Inspector/Medical Device Specialist in the
areas of imports, biologics, food safety, prescription and OTC drugs and medical device audits,
inspections and investigations. Practiced 13 years as an independent RA/QA consultant.
Experience in Quality System (QS) development and/or improvement in accordance with
Federal Regulatory Compliance, 483 response, cGMP, GCP, 510(k), IDE, and PMA projects.
Corporate Quality Systems auditor for Fortune 500 medical device manufacturer. Actively
managing the Internal Audit program and providing site assistance with updating SOP (Standard
Operating Procedures) content to ensure US and International Medical Device and compliance.
Expert Witness experience includes acting as consulting expert in matters involving investigative
medical device failure during clinical trial, and mammographic-quality issues.
Currently preparing for Lean Six sigma Training.
Professional Experience:
1996–2009
US and International RA/QA Specialist-Consultant
Projects include:
Review and assist with restructuring of product design and development process.
PMA, IDE, 510(k) submissions, pre submission audits, in addition to international Tech.
Files and Design Dossiers
Labeling review (includes marketing materials)
Establishment Registration and Listing
Development and implementation of recall strategy and MDR/MDV activities.
DMR/DHF/DHR evaluation & improvement
Assure company’s policies, procedures, work instructions and documentation are in substantial
compliance with US (21 CFR, ANSI/ISO/ASQ Q9000-200), ICH E6, EU (EN ISO
14971:2001, ISO 9001, 19011, 14969, 14001 and 13485, MDD (Medical Device Directive),
PAL, CMDA and SOR/98-282 regulations as they relate to the design, manufacture,
distribution and sale of regulated products.
CAPA Team Leader overseeing overhaul of deficient CAPA process and remediation activities.
Develop and manage internal audit program.
Performance of FDA mock audits in preparation for upcoming FDA inspection
OJT training of supplier and internal auditors as Lead Auditor
Project Manager: responsible for overhaul of audit processes. This included working with
engineers and analysts on team to develop data base feeder systems for trending and
implementing trend analysis in all applicable departments
Design and implementation of complaints program
Evaluation, revision and/or creation of SOPs, forms, and training materials for new/revised
procedures in collaboration with training department.
Review and audit QC inspection functions at receiving and final assembly.
Audit in-process product and processes for conformity.
Training of management, in all areas, of quality principles and implementation.
Assist with implementation, design and/or correction of QA/QC activities.
Creation and implementation of document control.
Site SME (Subject Matter Expert) for GDP (Good Documentation Practice).
Evaluation of Risk Analysis, GAP Analysis, FMEA and Vigilance system for substantial
compliance.
Consulting Expert Witness:
Consulting Expert providing QS (Quality System) review with investigative analysis of New
Product Development related to IDE and Clinical Trial Protocol.
Expert Witness as former FDA Mammography Quality Standards Act (MQSA) certified
Inspector in failure to diagnose case.
Consulting Expert in OTC product causing injury to consumer.
Clinical Trial Monitoring
1991 – 1996
U. S. FDA
FDA Investigator
Regulatory compliance activities which include but not limited to:
cGMP, GCP,
QA/QC inspection of blood banks, food processing, rendering, medical device, drug, clinical
and MQSA facilities.
Supervision of State contract personnel in carrying out FDA initiatives.
Investigative activities at facilities suspected of fraud and investigations into consumer
complaints.
Evaluation of labeling and promotional materials for compliance.
Collaborative FDA/USDA projects.
Conduct surveys of medical x-ray equipment.
Assist outside Federal Agency facilities in locating and correcting medical device performance
and SOP deficiencies.
Acted as the FDA Representative in collaboration with U.S. Customs, USDA, and the
Department of Fish and Wildlife to successfully produce and perform seminars for import/export
brokers on successful importation of foods, drugs, cosmetics and medical devices.
Oversight and training of junior inspectors
1978 – 1982
U.S. Navy:
Naval Hospital Corpsman, Neuropsychiatric Technician
Supervision of 5-6 subordinates
Training of staff in venipuncture technique
Medication administration
Relevant Skills, Knowledge and Abilities:
Strong base knowledge/understanding of principles involved in FDA and International
Regulatory requirements (21 CFR), ISO, ICH, ISO 13485, PAL, CMDR, MDD, cGMP, GCP,
QA/QC, HAACP and proven track record of easily transferring these skills for each type of
regulated industry.
Strong network within FDA.
Excellent technical writer.
Proficient computer skills.
Outstanding investigative and analytical skills.
Organized and results driven.
Management/supervisory and training experience.
Proven ability to work as part of team in accomplishing goals.
Extensive knowledge of medical terminology.
Short learning curve.
Excellent interpersonal/communication skills.
Beginning training for Lean Six Sigma Certification
Education:
Southern Methodist University, Plano, Texas, 2004 - 2005
Graduate studies in conflict management and dispute resolution in the workplace.
College of William and Mary, Williamsburg, Virginia, 1983 -1986
B.S. Biology
FDA Classroom Training:
Diagnostic X-Ray Survey. U.S. Department of Health and Human Services, FDA Center
for Devices and Radiological Health, Atlanta, Georgia.
Basic Radiological Physics. Uniformed Services University of the Health Sciences,
Bethesda, Maryland.
FDA Training Series for Interpersonal Skills. Baltimore District Reinvention
Conference, Baltimore, Maryland.
Microbiological Control. Department of Science, University of Wisconsin, Madison,
Wisconsin.
HACCP Department of Science, University of Wisconsin, Madison, Wisconsin.
FDA Food Device and Drug Law. U.S. Department of Health and Human Services,
FDA, Ft. Lauderdale, Florida.
The Reid Technique of Specialized Interviewing. Reid College, Ft. Lauderdale, Florida.
FDA Labeling Compliance. U.S. FDA, Baltimore, Maryland.
Prescription Drug Marketing Act. US FDA, Baltimore, Maryland
Professional Associations:
Southwest Conflict Resolution Network
Toastmasters International
References:
Available upon request.