History | Services | Team | Policies FDA Quality &
Regulatory Consultants LLC
ABOUT
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ABOUT US

A Fresh Perspective.
Trusted Compliance Solutions.

FDA Quality and Regulatory Consultants (FDAQRC) provides trusted compliance solutions to pharmaceutical, biotech, and medical device companies. From routine audits to inspection readiness to Quality Management System development, our Quality Assurance expertise spans all GxPs.

We provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk.

Mission

We use our technical expertise to contribute to the development of Life Science solutions.

Vision

Using risk-based assessments, we improve the health and welfare of the global population.

Values

We use Integrity, loyalty and ethical practices in all business transactions and treat all customers with respect.

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SINCE 2017
HISTORY

FDAQRC was founded in 2009 on the principals of communication and collaboration.

We take pride in our ability to provide the best possible customer service experience, for customers – both clients and consultants.

Since 2009, FDAQRC has grown our team internally and externally by acquiring sister companies and participating in global industry conferences. Our internal team primarily resides in the United States but we do have employees across the globe.

Today, FDAQRC’s relationships have grown to include experts with technical and scientific minds and quality and compliance professionals across the GxPs; from the laboratory, across human trials, to the manufacturing environment, and beyond to marketing approvals globally.

“The mock inspectors are challenging our audit
logistics in addition to our Quality Systems,
Clinical Operations and overall compliance.”
QA AUIDT MANAGER
“Consultant deliverable are
above expectations.”
SENIOR DIRECTOR, CLINICAL QUALITY ASSURANCE
“I think the FDAQRConsult is fabulous. I do love how
comprehensive it is. This is the kind of information
and resources I love to have for every audit I perform.”
CONSULTANT
“Working with FDAQRC gave me the
opportunity to develop a strategy to
move things forward.”
CONSULTANT
“FDAQRC was very cooperative, easy to work with
and very accommodating. They handled all of the
administrative details, which was very helpful. All interactions
were professional and collaborative.”
R&D QA, GLOBAL DIRECTOR
"I can always count on FDAQRC for a
prompt and helpful response.
GxP EXPERT ADVISOR
SERVICES

Global Expertise

Countries highlighted represent areas where FDAQRC works.

Our global reach extends to locations all around the world. To date, FDAQRC has connected 2,000+ projects in over 60 countries! We have more than 175 GxP Auditors in North America, 150+ in Western Europe, and over 400 worldwide.

Meet the FDAQRC
Internal Team

leadership and resources

Christopher Rush
President

M O R E . . .

Years of Experience: 15+
Founded FDAQRC in: 2009
Certifications: MBA

Chris inspected over 50 facilities including pharmaceutical and Bioresearch Monitoring (BIMO) inspections while working for FDA Chris was a member of the International Inspection Cadre and participated in six (6) inspections in Turkey, Bulgaria and Germany. He was presented with the US FDA Group Recognition Award, the US Food and Drug Administration Leveraging/Collaboration Award in May 2004 and the US FDA Outstanding Service Award in May 2006.

Chris took leave from the US FDA in 2007 and took his regulatory and inspection knowledge to a global IVD manufacturer where he worked as a Project Manager for Class II/III in vitro diagnostic (IVD) devices, his responsibilities included clinical trial monitoring, FDA submission and follow-up correspondence. Chris authored two (2) 510k applications that were cleared by the US FDA and assisted in the clearance of multiple other 510ks.

His experience transitioned well to a global pharmaceutical company where he conducted clinical QA audits, including routine and for cause audits that included all audit activities to assess compliance to established practices/standards and established regulations.

Steve Bliss
VP, Business Development

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2021
Certifications: MBA

Steve has a track record of proven success in creating mutually beneficial and profitable relationships with businesses, medical professionals, and consumers through multiple trade channels. His unique cross-industry experience includes life sciences, IT enterprise applications, business services, software, CPG-OTC and financial products and services.

Steve’s experience in working with small and mid-size companies is unique as he is exceptionally aware of their needs and the service, responsiveness, and consultation they require from a service provider to effectively support them.

Tammy Lesko
Sr. OPERATIONS MANAGER

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2018
Certifications: RQAP-GCP, MRQA

Tammy began her career more than 26 years ago in Good Manufacturing Practice (GMP) and transitioned to the US Food and Drug Administration as a Field Investigator with focus in GMP. At the FDA, she found her niche in Good Clinical Practice (GCP) with Bioresearch Monitoring Program (BIMO) inspections. After leaving the agency, Tammy’s primary focus has been GCP activities. She has provided GCP/Human Subject Protection, audit and inspection training presentations for several employers, clients, industry conferences and the Taiwanese FDA Investigators and Reviewers.

She has conducted hundreds of audits focusing on vendors (including CRO and IRBs), Investigator Sites, Trial Master File, Clinical Study Report, Due Diligence, and Inspection-related activities.

Tammy has a BS in Biological Science from Montclair State University.

Karen Andrews 
Resource Manager

M O R E . . .

Years of Experience: 15+
Joined FDAQRC in: 2018

Karen is a Quality Assurance Professional with more than 15 years’ experience in effectively managing the life cycle of audits. Experienced in tracking system support, producing, understanding and reporting metric data from multiple systems. Proven flexibility and proficiency in global customer support with experience in Quality System Management.

Janet Lee
Human Resources

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2016
Certifications: aPHR

Janet is a creative problem solver who enjoys connecting people with processes and resources which directly align with growth and development in a small company. Possess superior customer service and marketing skills with excellent written, verbal and interpersonal communication skills. Confident in the ability to make quick, calculated decisions and to think strategically in the moment. Flexible and resourceful with extensive experience in multi-tasking. Collaborates well within a team but thrives in self-directed positions by incorporating exceptional organizational skills and an acute attention to detail.

Janet has a Bachelors Degree in Speech Communications from Eastern Illinois University and a Master’s degree in Public Affairs Reporting from the University of Illinois at Springfield.

Kate Pfahl
Marketing 

M O R E . . .

Years of Experience: 5+
Joined FDAQRC in: 2020

Kate has a background in creative Marketing and has been an essential member of award-winning marketing teams. She has partnered with business development, sales, and operation teams to gain and maintain relationships with health providers, high-end retailers, lifestyle and entertainment brands. Kate manages our brand identity, social medias, and appearances at events.

Justin Clowers
Accounting 

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2009

More details coming soon!

Jessie Aric 
Accounting

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2018

More details coming soon!

project management

Michelle Copeland
DIRECTOR, pROJECT MANAGEMENT 

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2017
Certifications: RQAP-GLP/RQAP GCP

Michelle is a Quality Assurance (QA) professional with more than 10 years of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practice (GCP) and International Organization for Standardization (ISO) experience in a wide range of clinical and pre-clinical studies. She conducted a wide range of audits with complex protocols including those with vulnerable populations. She has performed audits throughout North and South America including investigator site audits, vendor audits, for-cause audits, and process audits.

She completed her Bachelor of Science in Biology at The Ohio State University. Michelle is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) and is an Active Member of the Society of Quality Assurance (SQA).

She completed her Bachelor of Science in Biology at The Ohio State University. Michelle is a Registered QA Professional in Good Laboratory Practices (RQAP-GLP) and is an Active Member of the SQA.

Sarah Bronstad
sr. pROJECT MANAGER

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2020
Certifications: MBA, RQAP-GCP/GLP

Sarah is a QA professional with 15 years of GLP, GCP and ISO experience in both pre-clinical and clinical studies with a main focus in medical devices. She is a Registered Quality Assurance Professional (RQAP) in both Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) through the Society of Quality Assurance (SQA).

Sarah started her career as a histology technician working on pre-clinical medical device studies and then transitioned into a clinical research role at a gastroenterology practice.

She has a AAS in Histotechnology, a BS in Health Sciences and a MBA with a Healthcare Concentration.

Erich Zirzow
Sr. Project Manager

M O R E . . .

Years of Experience: 20
Joined FDAQRC in: 2019
Certifications: MBA

Erich has worked in Clinical Research, Regulatory Affairs, and Quality Assurance. He has served as a Research Coordinator, Research Regulatory Specialist, Regulatory Compliance Manager, and Research Program Manager. His Regulatory and Quality Assurance experience includes conducting many internal, compliance, and investigative site audits.

Erich was fortunate to have worked on two of Cleveland Clinic’s largest groundbreaking clinical research studies that explored the genotypes that are responsible for premature coronary artery disease and heart attacks.

Erich He holds a Bachelor of Business from Franklin University as well as a Master’s of Business Administration from West Liberty University.

Amy Wotawa
Project Manager 

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2020
Certifications: MS

Amy is a Quality Assurance/Regulatory professional with over 10 years of experience in the biotechnology industry. She has a broad range of Quality Assurance/Regulatory Management experience from medical laboratory, pharmaceutical manufacturing, and food/dietary supplement manufacturing with expertise in improving products and facilities through driving regulatory compliance, quality assurance, policies, procedures, and projects. Amy has led multi-site, cross-functional teams through facility and product licenses, accreditations, certifications, internal and external audits, supplier quality management, project management, training development.

Camelia Kouki 
Project Manager

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2017
Certifications: PhD, CCRP, RQAP-GLP, RQAP-GCP

Dr. Camelia Kouki is a QA and Regulatory Affairs (RA) professional with more than 23 years’ experience in the research industry. Camelia began her career in cancer research where she spent five (5) years learning all the ins and outs of data management, drug management, laboratory, and clinical processes. She then had an opportunity to work as a Clinical Research Associate (CRA) for a renowned cancer institute where she had the honor of working with cancer patients and their Oncologists to help them find the best research study that would aid in their treatment and quality of life.

Camelia’s Quality Assurance (QA) experience became the center of her career once she joined a Contract Research Organization (CRO) to immerse herself in the US Food and Drug Administration (FDA) regulations and ISO standards as she built the quality unit from the ground up supporting therapeutic areas such as multiple sclerosis, asthma, cancer, pediatric, autoimmune, liver, infectious and heart diseases. Camelia has managed Good Laboratory Practice (GLP) and CLIA laboratories and rounded out her GxP experience as a QA/RA Director for a start-up medical device company driving the process to achieve FDA 510(k) clearance and CE Mark for the medical device and ISO 13485:2016 certification.

Amanda White
Project Manager

M O R E . . .

Years of Experience: 5+
Joined FDAQRC in: 2021

As a Project Manager at FDAQRC Amanda facilitates client communication and manage relationships while providing project oversight. Prior, Amanda gained experience by managing Quality & Regulatory Affairs for a Stem-Cell Transplant Program, Amanda also holds experience with Foundation for Accreditation of Cellular Therapy and designing Quality Management Plans and Systems.

Karen L Tracy
Project Manager

M O R E . . .

Years of Experience: 25+
Joined FDAQRC in:
2021

Karen is an experienced Project Manager specializing in Good Laboratory Practices (GLP). With over 25 years’ experience conducting quality control (QC) and quality assurance (QA) reviews of complex chemical and biological analytical data for GLP and non-GLP studies in regulated industries. Some of Karen’s experience includes conducting GLP studies and technical data reviews, writing protocols and final reports submitted to the US Environmental Protection Agency (EPA) for approval under the Toxic Substances Control Act (TSCA).

She holds a Bachelor of Science in Biology with a Chemistry minor from Valparaiso University and a Master’s of Business Administration from Indiana University (Northwest Campus).

Tristin Baca
Project Coordinator 

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2021

With 10 years of experience, Tristin comes with FDAQRC with hands on Phlebotomy and Laboratory experience, in addition to time spent in Good Clinical Laboratory Practice (GCLP) and Clinical Laboratory Improvement Amendments (CLIA). Tristin has also served as a Laboratory Clinical Trainer during COVID-19 which also entailed spending time on the frontline as an Area Site Manager.

Mia Walton
Project Coordinator

M O R E . . .

Years of Experience: 1+
Joined FDAQRC in: 2021
Certifications: BS, Biology

As a Project Coordinator at FDAQRC, Mia assists the Project Management team with resourcing needs. Mia maintains and manages data entries with our internal software’s such as FDAQRConnect and HubSpot. Mia comes to us with a degree in Biology and ample amount of customer and relationship services experience.

auditors

Kim Oldham 
Auditor & PM

M O R E . . .

Years of Experience: 15+
Joined FDAQRC in: 2021
Certifications: MS

Kim is a senior clinical research professional with a broad base of experience in quality assurance, data management, project management, and technology implementation for Phase I-IV pharmaceutical research. She specializes in Good Clinical Practice (GCP) computer system validation, including vendor audits, oversight of computer system validation activities and training for process and system owners. Kim is a skilled quality assurance auditor, planning and conducting multiple types of risk-based project, internal, system, and vendor audits and is experienced in design of global quality systems, including gap analysis, regulatory compliance assessment, and harmonization of multiple systems into a single quality system.

Randall Morris 
Auditor

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2019
Certifications: MSN, CRM

Randall has worked  in clinical care, clinical research, conducting inspections/audits, and regulatory affairs. He has worked as a Clinical Nurse, Clinical Research Nurse, Clinical Research Coordinator, FDA Investigator, and FDA Compliance Officer and his experience includes conducting many FDA investigator site audits and review of numerous cases as a compliance officer. Randall began working with FDAQRC after working as a Compliance Officer with the US FDA.

Randall earned his Master of Science in Nursing-Clinical Research Management from Duke University  an undergraduate degree in Nursing from Old Dominion University.

Bonita Thomsen
Auditor

M O R E . . .

Years of Experience: 30+
Joined FDAQRC in: 2020
Certifications: RN, RQAP-GCP

Bonita has 30+ years of experience in both early and late phase clinical research. In addition to a background in critical care nursing, Bonita has a variety of experience in Quality Assurance – working in the Site Management Organization and academic environments, internal and emergency medicine research populations, and GCP auditing.

Bonita has been a part of many therapeutic audits, including but not limited to; Special Populations, Healthy Normal Volunteers, First in Man, General Cardiology, Cardiac Electrophysiology/Devices, Emergency Medicines, Infectious Diseases, Orphan Diseases, Drug Delivery Systems/Devices, Coagulation Disorders/Reversal Agents, Pulmonology, Endocrinology, Nephrology, Psychiatric, Neurology Biologics, Radiopharmaceuticals, Vaccines, Pediatrics, Anti-Venom, Dermatology, Podiatry, Controlled substances, nutritional products, and In-Vitro Fertilization.

Alex Loboda
Auditor

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2021

Alex is a highly motivated, experienced clinical quality professional with extensive knowledge in Good Clinical Practices (cGCP’s), Good Laboratory Practices (cGLP’s), Good Pharmacovigilance Practices (cGPVP’s) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). With hands-on experience in planning and execution of GCP compliance strategy and Quality guidance for clinical stage development programs, Alex has developed, implemented, and maintained the client’s clinical quality management framework to ensure compliance with applicable national and international regulations and standards.

In addition, Alex has built, trained, and managed a team of internal and external resources to achieve company goals and objectives; planned and conducted inspection readiness activities and provided support for audits and regulatory authority inspections of internal clinical units and investigational sites. Alex has experience with growing small and large-scale pharmaceutical and biotech companies to achieve optimum utilization of its resources and maximum profits. Alex has extensive experience conducting Investigator Site Audits (ISA) and Vendor Audits.

Dawn Wydner
Auditor

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2017
Certifications: BSN, MS

Dawn has extensive U.S. Food and Drug Administration (FDA) Regulatory Compliance and Industry Quality and Compliance expertise. Dawn has been a sought out Subject Matter Expert with a proven track record of consistently establishing proactive compliance and application of quality oversight. She offers a firm grasp of all aspects of operational strategy, coordination and conduct of all Pharma R&D, Medical Device and Consumer markets; audit and compliance, safety and quality monitoring; and operational risk management across all GxPs. Dawn has more than 10 years’ experience as an US FDA Inspector, where she led and conducted Bioresearch Monitoring (BIMO) GCP and GLP inspections, Post Marketing Adverse Event Reporting (PV) inspections, drug and device GMP inspections assessing compliance with FDA regulations, Biologics inspections enforcing GCP, GLP, GMP, et al. Consultant is highly skilled in identifying non-compliance issues which resulted in several significant Regulatory outcomes.

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