Summary of Qualifications

• Provides interpretation and/or consultation with respect to regulations, guidelines and standards, and the compliance status of functional area processes and procedures.

• Author or key collaborator on more than 200 SOPs and form improvements, including Inspection Readiness and GXP Quality Management System procedures.

• Evaluated dozens of clinical, analytical, and toxicology vendors for regulatory compliance.

• Recruited, trained, and managed teams of up to 3 people, including senior managers; mentored a total of 8 direct reports.

• Audited more than 200 bioanalytical, pharmacokinetic and analytical study phases.

Professional experience

Koko Clinical Quality, LLC                                                                   2022 to present

President and Principal Consultant (2022 to present)

• Develops SOPs, policies, plans, forms, manuals and templates.

• Performs gap analyses and risk assessments.

• Provides consultation and training with respect to:

  • Learning management system design and implementation.

  • Vendor management system design and implementation.

  • Inspection management system design and implementation.

• Performs vendor qualification and routine audits, and provides consultation related to vendor issue management.

• Trains and prepares clinical investigator sites for inspection.

• Supports inspections at vendors or partners.

• Develops training curriculums.

• Provides GxP training.

Heron Therapeutics                                                                              2017 to 2022

Director, Quality Assurance GCP/GLP (2019 to 2022)

Associate Director, Quality GCP/GLP (2017 to 2019)

• Developed, implemented, and maintained the company’s GCP/GLP quality management system and facilitated continuous improvement.

• Provided GCP QA operational oversight, supported internal clinical functions and represented QA in project team meetings as the quality representative.

• Oversaw the development/maintenance of SOPs and other quality documents in Drug Development.

• Lead continuous improvement initiatives and activities.

• Developed and implemented audit plans and yearly GCP/GLP/GVP audit schedules.

• Scheduled, oversaw and performed routine and non-routine QA audits to include: clinical investigator sites, animal testing facilities, analytical vendors, processes and systems.

• Supported external GLP testing to ensure compliance with guidelines, SOPs, protocols and industry standards.

• Maintained a GLP organizational list, monitored each GLP study and study phase to provide assurance that the facilities, equipment, personnel, methods, practices, and controls employed were in conformance with the USFDA GLP regulation, maintained the master schedule, and submitted periodic status reports to management.

• Conducted QA review and/or audits of GLP methods, protocols, data and reports.

• Selected external auditors, coordinated audits and assured/coordinated proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of CAPA plans, as necessary.

• Conducted QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.

• Prepared Heron, investigational sites, and GCP/GLP/GVP vendors for regulatory inspections and audits performed by regulatory authorities and other parties.

• Scheduled and/or delivered yearly GCP/GLP/GVP training for internal staff.

Samumed, LLC                                                                                          2016 to 2017

Senior Quality Assurance Manager (2016 to 2017)

• Served on the Risk Based Monitoring (RBM) Sub-Team to develop the Integrated Quality Risk Management Plan, Central Data Monitoring Plan and the Vendor Management Plan, and to evaluate RBM and CTMS platform candidates.

• Worked with outsourcing functional groups and the legal department to develop a new policy and related procedures for GXP vendor identification, risk categorization, CDA timing, requests for proposal (RFP), vendor selection and contracts, oversight planning and execution, and qualification status monitoring. Designed an intranet-based electronic form for QA notification of new vendor needs to trigger qualification activities.

• Performed a CSR audit and later worked with the clinical team to develop a CSR SOP and template.  Developed a tracking system and reporting template for internal audits.

• Reviewed acceptability of site CAPA documentation related to improper access to blinded study information, and made recommendations regarding root cause analysis and impact assessment.

• Coordinated and conducted external audits to ensure compliance with applicable regulations, protocols, and SOPs. Audited a Phase 1 site and clinical laboratory, a bioanalytical laboratory, two analytical laboratories and two toxicology facilities.

Ardea Biosciences, Inc.                                                                          2009 to 2016

Senior Quality Assurance Manager (2015 to 2016)

• Managed the GCP QA audit program; maintained the audit database and files.

• Coordinated and conducted external GCP audits to ensure compliance with applicable regulations, guidelines, protocols, and SOPs. Audited investigational sites and clinical laboratories, and issued formal audit reports and observations within 10 business days.  Assessed qualifications of a Brazilian CRO remotely (including Part 11 compliance and vendor/site qualification policies) within 15 days of notification from the clinical team.

• Conducted internal GCP clinical study report audits in a rolling review format to accommodate tight timelines, whereby color coding was used to identify the stage of review applicable to each section of the CSR; verified contents of trial master files against the approved TMF plans and reported observations within one day. 

• Developed the workflow for tracking regulatory inspections and reviewing inspection findings (such as FDA 483/EIR) for sites; provided feedback to Clinical Operations within 24 hours in support of site selection and planning of risk based monitoring activities.

• Tracked and logged site and vendor issues; met with the clinical team monthly to follow up on open escalation items in order to advise on risk assessment and most logical use of resources toward a defendable course of action.

• Developed trial-specific audit plans, and provided quality system assessments for vendor documentation (eg, Statements of Work (SOW), laboratory manuals, eDiary specifications) for phase 1 through 5 clinical trials.  Together with the study team, coordinated finalization of vendor and Investigator Meeting documentation three weeks ahead of schedule to accommodate changing timelines.

• Transferred requested audit records and access to data in support of regulatory applications to new marketing partners within 10 days.

Quality Assurance Manager (2013 to 2015)

• Trained and managed three junior auditors, with focus on risk assessment, objectivity, clear communication of findings as related to the respective SOP or regulation, categorization/classification of findings to allow for metrics, and management of the audit program to ensure that quality oversight could be demonstrated during a regulatory inspection.  Met with each auditor monthly to evaluate workload, to communicate and receive feedback, discuss career development opportunities, and manage any concerns.

• Traveled to Beijing one month prior to the announced EMA GLP inspection of the Chinese Test Facility to provide 5 business days of intense inspection readiness training, to help prepare the study personnel for interviews, and to ensure ready‑access to electronic raw data and validation packages; returned to Beijing and provided backroom and scribe support of the successful EMA inspection of the Test Facility.

• Directed inspection readiness activities for an EMA requested FDA GLP inspection of study phases conducted at Ardea; created and led sub-teams for: inspection management, electronic data access logistics, Subject Matter Expert (SME) refresher training, facility tour logistics, and study documentation retrieval. Within 5 days of return from the inspection in China, coordinated retrieval of archived study phase materials related to the studies inspected by the EMA and scheduled blocks of time for study personnel to review and again become familiar with study details in preparation for the FDA inspection.

• Scribed during the GCP focused FDA inspection and provided daily updates to executive management regarding inspection progress and the status of any open requests; the inspection resulted in no 483 observations.

• Managed the back room and request fulfillment, and acted as the SME for QA during the GLP focused FDA inspection; remained on site after the inspectors left each day until all requests were fulfilled and ready for the inspectors the following morning.  The inspection resulted in one 483 observation.

• Coordinated contract auditors and SMEs for site visits and regulatory inspections, including collaboration with legal on contract agreements and SOWs; generated purchase orders via eRequester.

• Reviewed slides and coordinated scribe procedure for a successful FDA Advisory Committee meeting.

• Evaluated compliance and contributed guidance during review of SOPs, forms, protocols, study reports, deviation reports, unanticipated event reports and root cause analysis investigations. 

• Verified adverse event and deviation reporting against Tables Figures and Listings, reviewed tests performed against Informed Consent Forms and ensured patient confidentiality within bioanalytical and pharmacokinetic study phase files.

• Proposed, designed and implemented GLP Challenge in 2014 and GLP Family Feud in 2015 as annual GLP and Part 11 refresher training for more than 60 people.

• Pioneered use of OneNote for quality system project collaboration, implemented the SharePoint web application and MS Lync for inspection front‑room/back-room management, and introduced Outlook folder sharing for maintaining electronic correspondence for in-progress studies and projects.

• Employed the electronic data management system (SharePoint based repository with Part 11 compliant electronic signature approval functionality) for maintenance of the Master Schedule, Management Status Reports and the Organizational Chart that allowed for remote review and approval, and validated version history.

• Assisted in the development and processing of consultant auditor contracts and budgets, and reviewed/approved contracted deliverables and invoices.

Senior Quality Assurance Associate II (2011 to 2013)                                      

• Recruited five previous analytical science colleagues for open scientist positions.  Recruited and mentored a new auditor who made the switch from scientist to Quality Assurance; fostered career development via one-on-one training and constant availability as a resource and advocate.  The auditor later went on to lead the GLP QA function at Ardea.

• Trained and managed the document control specialist/archivist who began as an intern; introduced him to aspects of Quality Assurance outside his job description such as the requalification of Iron Mountain, compliance training, and management of equipment calibration schedules and documentation in support of his career development and industry knowledge.

• Managed and filled due diligence requests from potential partner companies within 48 hours of receipt.

• Recommended and coordinated a mock inspection to be performed by C.T. Viswanathan, former Associate Director and Chief of the BE and GLP Investigations Branch of CDER, FDA, who provided training to hundreds of FDA (also OECD and Health Canada) inspectors to carryout effective inspections of the pharmaceutical industry and CROs; hosted the mock inspection and ensured feedback from Dr. Viswanathan was incorporated into inspection readiness activities and training.

Senior Quality Assurance Associate (2009 to 2011)

• Reviewed electronic data, audit trails and validation packages for Analyst (Sciex), Watson LIMS (Thermo), TotalChrom (Perkin Elmer), ChemStation (Agilent), Empower (Waters), and Provantis (Instem).

• Evaluated fledgling bioanalytical systems and staff, and recommended changes to documentation and system flows which were implemented by Test Facility Management; the next independent audit showed marked reduction in observations and all previously identified major deficiencies were resolved.

• Performed qualification and data review visits at bioanalytical, toxicology, biomarker, central lab, and phase 1 vendors.

BioAgilytix (formerly MicroConstants, Inc.)                                          2004 to 2009

Quality Assurance Supervisor (2008 to 2009)

• Hosted sponsor and consultant quality audits.

• Trained new QA employees; evaluated performance of bioanalytical and analytical staff against their training programs and reported conclusions.

Quality Assurance Auditor (2006 to 2008)

• Performed audits of pharmacokinetic and toxicokinetic data, ensuring 100% of supporting documents necessary for study reconstruction were filed within the study phase documentation.

• Performed internal audits to verify compliance with established company/department procedures and identified areas for improvement.

• Defined System Requirement Specification for QA functions and developed audit strategy for stability and maintenance schedule tracking in the LIMS.  Reviewed IQ, OQ, PQ, and validation summary documentation.

Senior Analytical Scientist (2006 to 2006)

• Managed bioanalytical studies, and reviewed laboratory notebooks, raw data and other applicable documents/records.

• Performed routine sample analysis, raw data documentation and report writing for determination of pharmaceuticals in biological fluids.

Analytical Scientist (2004 to 2006)

• Validated bioanalytical methods for determination of pharmaceuticals in biological fluids, documented raw data and wrote reports.

• Performed ELISA analysis using KC4 software and handled purchasing orders for the large molecule assays.

Professional development

 10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program, Barnett International, 2022

Introduction to FDA GLP Bioresearch Monitoring Compliance Program (Virtual), SQA

Advanced GCP (Virtual), SQA, 2022

FDA Remote Record Reviews: A Comparison from 2 CROs (Online), SQA, 2022

GLP Study Director and Principal Investigator Training (Online), SQA, 2021

Over the River and Through the Woods: Following the Audit Trail (Online), SQA, 2021

Remote Audits and Inspections: The New Reality (Online), SQA, 2020

The Mistake of Using Human Error to Assign Accountability in CAPA (Online), SQA, 2019

EU Pharmacovigilance System Master File (PSMF): What is it? (Online), SQA, 2019

Intro to Basic PV Requirements for Quality Professionals (Online; 4 weeks), SQA, 2019

Intro to 21 CFR Part 11: Electronic Records; Electronic Signatures (Online), SQA, 2019

Introduction to Writing Effective Compliant GLP SOPs (Online), SQA, 2019

GLP Study Director and Principal Investigator Training (Online), SQA, 2018

Clinical Research Conference West, MAGI, 2018

GCP Hot Topics and Industry Trends, SQA, 2018

GCP Advanced Training, SQA, 2018

Annual Meeting/Fall Training, PRCSQA, 2017

Clinical Research Conference West, MAGI, 2017

Quality Tolerance Limits in RBM, 2017

GCP Data Stewardship, SQA, 2016

GCP Beyond the Basics, SQA, 2016

Good Clinical Practice: Understanding the Basics (Online), SQA, 2015

Electronic Archiving and Digital Decay, SQA, 2014

Management Development Academy, BEDC, 2013

GLP Modern Approaches to QA Strategies, RQA (UK), 2013

Archiving 101: What You Need to Know About GLP-Compliant Archives, SQA, 2013

Current Topics in Good Laboratory Practice, SQA, 2013

Hosting Client Audits in GxP Environment, SQA, 2013

Why is FDA at My Facility, What Do I Do During an Inspection? Compliance Online, 2013

Good Clinical Laboratory Practices (GCLP) Auditing, SQA, 2012

Current FDA GLP Topics, for Monitors and Facility Management, D. Garvin, 2012

Good Clinical Practice: Beyond the Basics, SQA, 2012

Watson 7.4.1 with Sample Handling, Thermo Fisher, 2012

Regulatory and Scientific Approaches for 21st Century Bioanalyses, SQA, 2011

Current Topics in Good Laboratory Practice, SQA, 2011

Good Clinical Practice: Understanding the Basics, SQA, 2011

Application of GLP Principals, D. Garvin, 2011

IVT Annual Validation Week, Philadelphia, 2010

Spreadsheet Validation: 21 CFR Part 11 Compliance, FOI, 2010

Critical Components of GLP Compliance, D. Garvin, 2010

The Brass Tacks of GLP, enKap, 2010

Writing Effective GLP Documents, enKap, 2010

Advanced Training, Good Laboratory Practice, SQA, 2007 and 2008

Quality Assurance Audits, Inspections, and Responsibilities, D. Garvin, 2006

Take the Mystery out of HPLC: The Training Masters, R. Wong, PhD, 2005

Professional memberships

 Society of Quality Assurance

Registered Quality Assurance Professional in GCP (2018 to present)

Registered Quality Assurance Professional in GLP (2010 to present)

Education

 Certificate, Biomedical Quality Systems                               San Diego State University

• GMP, GCP and GLP

BS, Biological Sciences                                              California State University, Chico

• Focus in Microbiology; Minor in Chemistry