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EXPERTISE
Experienced
and successful quality assurance professional with 17 years
at FDA and expertise in GCP, GLP, and pharmacovigilance. Works
effectively with diverse groups across the spectrum of clinical
research and FDA regulated industry. Skilled in assessing
the state of regulatory preparedness at companies, contractors,
and clinical sites with expertise in auditing as well as the
inspection skills to identify clear and significant violations
of FDA regulations. Strong experience successfully training
and preparing research professionals for regulatory inspections.
International experience includes Canada, Europe, the Middle
East, and East Asia.
EXPERIENCE:
CURRENT
POSITION Oct. 2007 to present: |
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Senior
Consultant,
Biologics
Consulting Group, Inc., Tacoma, WA.
- Provides
GCP, GLP, and pharmacovigilance consulting, audits,
and training to clients in the biotechnology, medical
device, and pharmaceutical industries and public agencies
to develop quality assurance and regulatory strategies
for compliance with FDA regulations and ICH guidelines
by:
- Conducting
mock FDA inspections of clinical investigators,
sponsors, contract research organizations, GLP
laboratories, and company pharmacovigilance departments.
- Developing
response and corrective action to FDA 483s and
Warning Letters.
- Providing
GCP oversight and auditing of contract services
(clinical laboratories, core laboratories, and
data management).
- Designing
and implementing GCP, pharmacovigilance, and GLP
training programs.
- Developing
and reviewing Standard Operating Procedures.
- Developing
and augmenting clinical and GLP quality assurance
units.
- Auditing
and reviewing trial master files, clinical study
reports, and document systems
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| 2005
- Sep. 2007 |
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Senior
Consultant, Quintiles Consulting, Tacoma, WA.
- Assisted
clients in the pharmaceutical, biotechnology, biologics,
medical device industries, and public agencies develop
quality assurance and regulatory strategies for compliance
with FDA regulations and ICH guidelines by:
- Conducting
assessments of client studies, procedures, vendors
and programs to determine regulatory compliance
for data integrity and the protection of human
subjects in research.
- Conducting
internal and external quality assurance audits
for compliance with GCP, pharmacovigilance, and
GLP regulatory requirements.
- Developing
and implementing corrective action plans to address
FDA 483 observations, FDA Warning Letter citations
and other regulatory deficiencies.
- Presenting
GCP and other regulatory training at conferences,
clinical sites, and client sites.
- Developing
quality policies and procedures.
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| 1994
- 2005 |
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Consumer
Safety Officer, FDA
- Conducted
bioresearch monitoring and drug GMP inspections of
FDA regulated industry.
- Inspections
included clinical investigators, sponsor-investigators
(investigator initiated research), sponsor/contract
research organizations/monitors, institutional review
boards (IRBs), pharmacovigilance, and nonclinical
laboratories (GLP).
- Conducted
international inspections in Europe and Canada for
clinical investigators, pharmacovigilance, and active
pharmaceutical ingredients.
- Conducted
for-cause audits and investigations regarding research
misconduct.
- Advised
FDA's Office of Criminal Investigation on GCPs in
their investigations.
- Organized
and conducted outreach programs to regulated industry
and university extension services including presentations
on the FDA inspectional process of clinical trials,
protection of human subjects in clinical research,
FDA inspections of IRBs, and FDA regulation of non-clinical
laboratories.
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| 1992
- 1994 |
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Biologist,
FDA
- Analyzed
official and import samples in the microanalytical
and color/food additives laboratories.
- Conducted
team inspections with the Investigations Branch for
bioresearch monitoring and biologics assignments.
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| 1990
- 1992 |
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Biological
Laboratory Technician, FDA
- Prepared
samples for analysis in microanalytical, color/additives,
and seafood laboratories
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| 1987
- 1990 |
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Support
Staff, FDA
- Worked
in three support positions in Compliance Branch, District
Director's Office, and Investigations Branch.
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MEMBERSHIPS
Society
of Quality Assurance
Organization of Regulatory and Clinical Associates
Advisory board for The Immel Report.
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PUBLICATIONS
Anderson,
C., Tashiro C., Taddonio, L., Vendor Quality Assurance
Audits: A Formula for Success, Applied Clinical Trials,
May 2007
Anderson,
C., Protocol Adherence and Recordkeeping: The Twin Pillars
of GCP, The Immel Report, Vol. 1, No. 5, 2005
Anderson,
C The FDA 483 The Immel Report, Vol. 1, No. 3, 2005
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EDUCATION
| 1992-1993 |
Career
Opportunity Training Agreement, FDA. |
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Completed
18 month FDA career development program resulting
in appointment as Biologist. (This training serves
as an equivalent to a B.S. degree for DHHS/FDA) |
| 1992-1996 |
UC
Berkeley Extension, Berkeley, CA, Writing |
| 1988-1992 |
Laney
College, Oakland, CA, Biology |
FDA
SPONSORED TRAINING
| 2004
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Advanced
GLP Inspections, U.S. Food & Drug Administration |
| 2004
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Two-Month
Detail: Consumer Safety Officer, CDRH/Office of
Compliance/Division of Bioresearch Monitoring,
US Food & Drug Administration
This assignment included reviewing EIRs from field
offices and writing regulatory correspondence,
including warning letters. This is the office
that oversees inspections of IRBs.
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| 2004
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Electronic
Diaries in Clinical Trials, CDRH/Food & Drug
Administration |
| 2002 |
FDA
National Bioresearch Monitoring Conference, Seattle
District Representative, US Food & Drug Administration |
| 2002 |
Protecting
Human Subjects: Safety, Welfare, and Privacy, FDA,
OHRP, VA, Western IRB, UW, and Fred Hutchinson Cancer
Research Center |
| 2002 |
Detail:
Supervisory Investigator, Seattle District Investigations
Branch, U.S. Food & Drug Administration |
| 2001 |
Pre-Approval
Inspection Training Course, U.S. Food & Drug
Administration |
| 2001 |
Orientation
to International Inspections, U.S. Food & Drug
Administration |
| 2000 |
Basic
Drug School (GMPs), U.S. Food & Drug Administration |
| 2000 |
Conducting
Successful Clinical Trials, U.S. Food & Drug
Administration and University of California, San
Francisco |
| 2000 |
Inspections
of Computerized Systems, U.S. Food & Drug Administration |
| 1998 |
1998
Quality Auditing, U.S. Food & Drug Administration |
| 1997 |
Inspections
of Nonclinical Laboratories, U.S. Food & Drug
Administration |
| 1996 |
Clinical
Bioresearch Monitoring, U.S. Food & Drug Administration |
| 1995 |
Investigative
Interviewing, U.S. Food & Drug Administration |
| 1993 |
Evidence
Development, U.S. Food & Drug Administration |
| 1993 |
Basic
Food and Drug Law, U.S. Food & Drug Administration |
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Page
Updated:
October 4, 2007
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