About QACV
QACV was founded in 2001 and has provided quality assurance, compliance, and computer validation services to the life sciences industry for over 22 years. During that time period, all of QACV’s business has been by word of mouth referrals and repeat work from satisfied customers. This website was developed by customer request to provide additional information about QACV and the services we provide.
QACV is successful when our customers are successful and we strive to provide personalized services that are effective, efficient, and value added. There are many ways to be in compliance and QACV’s qualifications and experience will provide you with the recommendations that best fit your organizational needs. With skill sets in compliance, project management, six sigma, and validation, QACV offers a combination of unique services and solutions that will meet your regulatory challenges.
QACV will use….
- EVERY OPPORTUNITY to provide high quality, cost efficient, professional, and personable consulting services to our clients.
- EVERY OPPORTUNITY to meet and exceed our client’s expectations and requirements.
- EVERY OPPORTUNITY to provide right-sized and scalable consulting support to help clients of any organizational size to meet their objectives.
- EVERY OPPORTUNITY to proactively identify and eliminate potential project issues.
- EVERY OPPORTUNITY to be responsive to client needs, expectations, schedules and timelines.
- EVERY OPPORTUNITY to provide appropriately trained and qualified personnel to support client projects.
Chris Wubbolt, M.S.
Principal
Chris has over 25 years experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services since 2001. Specializing in computer systems compliance, including validation, as well as quality assurance activities such as auditing, training, and six sigma quality improvement processes. Prior to consulting, Chris worked at Hoffmann-La Roche, Aventis Pasteur, Johnson & Johnson, and Lancaster Laboratories in several compliance and validation functions, including Group Leader/Manager of Computer Validation, Product Complaints and Supplier Audits, leading and supporting both global and site compliance and validation efforts. Chris remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris was a contributing member of the ISPE GAMP Laboratory Systems Special Interest Group, which published the Good Practice Guide “Validation of Laboratory Computerized Systems” and was a chapter chair and editorial board member for the DIA’s recent publication “Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts.” Chris has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Erika Reategui
Vice President of Compliance
Erika is a highly experienced Molecular Biologist with a remarkable track record of over 25 years in clinical research, with several certifications as a Clinical Research Professional, Certified Community Health Worker, and Certified Clinical Research Contract Professional. With a strong background in regulatory environments, including FDA, MHRA, Health Canada, and EMA, Erika has consistently demonstrated exceptional expertise and knowledge in navigating the complex landscape of clinical trials, regulatory compliance, and drug development.
Throughout her career, she has focused on head and neck cancer research and early detection testing, accumulating over 13 years of experience in this field. In addition to her expertise in head and neck cancer research, Erika has extensive experience in early-phase and late-phase environments, including both GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) environments. This expertise ensures that all research activities adhere to rigorous quality standards and regulatory requirements, guaranteeing the integrity and reliability of the data generated.
Erika also possesses a deep understanding of GMP (Good Manufacturing Practice) and GVP (Good Pharmacovigilance Practices) principles, acquired through four years of experience in these areas. This knowledge enables her to effectively collaborate with manufacturing teams and monitor the safety of medicines to ensure the production of high-quality and compliant pharmaceutical products.
Throughout her career, Erika has made significant contributions to the field of molecular biology and clinical research. She has authored numerous publications in peer-reviewed journals and has presented her research and findings at international conferences as an expert in the field.
John Patterson, M.S.E
Senior Consultant
John has recently joined the QACV Consulting team with over 30 years of bio-pharmaceutical experience in several different roles including engineering, technical operations, manufacturing, quality assurance and information technology. Mr. Patterson possesses current skills in the development and deployment of quality management systems, risk management frameworks, quality auditing & governance and computerized systems validation including infrastructure qualification (including Cloud IAAS), application (MES) validation and GxP data integrity assurance.
John also possesses significant experience preparing, managing and responding to IT & automation topics during GMP & GCP regulatory inspections. Mr. Patterson has also been involved with bringing cybersecurity to GxP systems and has been responsible for establishing an information security and data protection capability in his most recent role. John keeps his skills current through regular speaking engagements at industry conferences, active involvement with multiple ISPE and industry SIGs and authoring/co-authoring of technical articles in leading industry publications including topics such as MES Validation (Institute of Validation Technology – IVT), Risk Management (ISPE Baseline Guide, Oral Solid Dosage Forms) and Bringing Cybersecurity to GxP Systems (Pharmaceutical Engineering Magazine). John has a M.S. in Engineering from Purdue University and a B.S. in Agricultural Engineering from the University of Wisconsin-Madison.
Angela Haan
Sr. Compliance Consultant (GLP)
Angela Haan, Senior Compliance Consultant (GLP) at QACV Consulting, provides GLP guidance, GLP compliance audits, study support, and data and report review support. Angela has a master’s degree in pharmacology/toxicology from Michigan State University and RQAP-GLP certification from Society of Quality Assurance since 2013. Previously, Angela worked at Charles River Laboratory (formerly MPI Research) for 13 years. Her preclinical experience included roles as Research Technician, Report Coordinator, Quality Assurance Auditor, and Study Director. In 2019, Angela began working independently as a GLP consultant at Illuminated Quality Services and has worked in collaboration with QACV Consulting since 2021. She also has managerial experience in a GMP/GCP setting. Angela currently lives in Grand Haven, MI.
Marianne Barnes
Sr. Compliance Consultant
Marianne is a Cyber Security professional with 20 years of experience at Sanofi, a large global Pharmaceutical / Biotech organization. In 2019, she worked closely with the Global Privacy and Legal teams at Sanofi to create and implement a comprehensive program with tools and training to ensure employees, contractors and computer systems were in compliance with the Global Data Protection Regulation (GDPR).
Previous to this she led a team of 30 technical experts who were responsible for assessing and implementing security and quality controls to ensure that they were in compliance with regulatory laws (FDA, HIPAA, Sarbanes-Oxley and GDPR). She successfully implemented large Cyber Security and Quality programs that included:
- Awareness training program for IT and End Users
- Global Computer Security and Quality and Compliance policies and procedures, including annual review and updates
- Computer Security Standards & Technical Guidelines for computer systems
- Incident Response plans and exercises
- Risk Assessments of infrastructure, operating and application systems
- Third Party Risk Assessments / Audits of Computer Systems
- Vulnerability Assessment and Penetration Testing
Since joining QACV, Marianne has led the efforts in the following areas:
- Application Security Assessments and remediation activities
- General Data Protection Regulation (GDPR) and Privacy assessments and remediation activities
- Developed and deployed training and awareness programs for the General Data Protection Regulation (GDPR)
- Plan, conduct and report results of Computer Systems Validation activities and gap analyses.
- Plan, conduct and report results of Computer Systems audits, including audits of distribution centers; trial master files; contract manufacturers and PETNET solutions.
- Implemented an improved Computer Systems Compliance program, including Computer Validation for computer software companies
- Led the development of remediation plans for observations which were identified through internal or external audits
- Audited critical suppliers including medical device, pharmaceutical, packaging, inventory, software and service providers against USFDA 21 CFR, ISO 13485, ISO 9001, ISO 17025, ISO 27001 and ISO 27701
Chris Mondello
Sr. Compliance Consultant
Chris Mondello joined the QACV Consulting team in March 2020. Prior to QACV, Chris’ experience in the pharmaceutical and biotech industries spans several decades. That experience includes:
- working on and leading a pharmaceutical R&D software development organization that focused on building real-time laboratory automation applications,
- managing a wide variety of electronic system validation projects,
- conducting many workshops on computer system validation and FDA’s 21 CFR Part 11 regulation, and
- leading an electronic system compliance group that was responsible for providing oversight and guidance on all systems used in a variety of pharmaceutical / biotechnology R&D areas, and other functional areas, including pharmacovigilance, clinical operations, regulatory operations, medical affairs, biostatistics, data management, non-clinical laboratories, and legal records systems.
Since joining QACV he has conducted upwards of 100 third-party and internal audits for our clients.
Chris holds these certifications from the American Society for Quality:
- CQA – Certified Quality Auditor (certification #42361) since 04-Jun-2011
- CSQE – Certified Software Quality Engineer (certification #5206) since 02-Jun-2012
He also has an ITIL Foundation Certificate in IT Service Management from the PEOPLECERT Group (certification #GR750047997CM) dated 21-Feb-2013.
Chris earned an M.S. in organic chemistry from Northeastern University (Boston), and a B.S. in chemistry from Houghton College (now Houghton University, Houghton, NY)
Chris is a member of the board of directors for Project Response (Brevard County, Florida), a non-profit organization that has provided a safe space for HIV/AIDS services for over 30 years.
Chris Townsend
Sr. Compliance Consultant
Chris Townsend has been consulting since 2012. Prior to consulting he worked for 14 years as a laboratory technician, trainer, validation lead, and system administrator in pharmaceutical and vaccine production. His experience as a chemist started when CFR Part 11 was in its infancy and many systems were paper based. Chris has been fortunate to watch the progression of the industry from paper to software, which gives him a unique understanding of data integrity. He has experience with many different systems in laboratory and production. Chris audits, remediates, and assists businesses to meet regulatory expectations.
Russell Wilson
Client Lead/Sr. Compliance Consultant
He is dedicated to ensuring that your projects are completed with unparalleled customer service and quality. With over 15 years of experience in biopharmaceutical QA, my background spans the full breadth of GxP through every phase of drug development (preclinical to commercial). With principle expertise in GMP, Russell has worked on projects supporting the manufacturing of most types of therapies including drugs, biologics, sterile injectable/ophthalmic, cell and gene therapies, radioactive PET tracers, in vitro diagnostics, RNA therapeutics, devices, combination and OTC products. Holding a Ph.D. in Pharmaceutical Sciences and an MS in Quality Assurance and Regulatory Affairs, he can also support more specialized GxP projects according to the breadth of education and experience I have obtained through the years. He looks forward to working with you on your projects and ensuring that QACV Consulting helps your products reach your patients in a safe and compliant manner.
Jayvin Amigo
QA Manager and Project Manager
Jayvin is a highly skilled Supplier Quality/Quality Compliance professional with over 12 years of experience
in ensuring the quality and compliance of internal and external processes in various industries, including biopharmaceutical and medical devices. With an Industrial Engineering background, Jayvin’s expertise in process optimization, systems integration, and driving continuous improvement initiatives at QACV Consulting will undoubtedly maximize efficiency and productivity and ultimately deliver customer satisfaction.
Mike Sobczyk
Sr. Compliance Consultant
Mike Sobczyk has a Bachelor of Science Degree in Biology from the University of Nebraska at Omaha and a Master of Health Sciences from George Washington University. Until recently, Mike was working at Gilead Sciences Inc. as the Executive Director of R&D Quality and Compliance (approximately 11 years). Over the past 30 + years, Mike’s responsibilities have included oversight of GCP, PV, GLP, GMP, Electronic Systems/Computer Validation, Training and Quality Management System. In addition, Mike developed a class in Clinical Research Auditing that he taught for two years at Boston University. Over Mike’s career he has had an opportunity to facilitate several FDA and International inspections (MHRA, EMA, PMDA, TGA, FDA etc). In addition, he has had the opportunity to develop and present a 6-day long GCP and GLP class for the policy makers of the Chinese government. Also, Mike has represented industry for several years at DIA Annual Meeting as a co-presenter with the FDA and EMA. Prior to Mike’s quality assurance experience, he spent several years as the Technical Director of Bishop Clarkson Hospital Renal Disease Center which included working with the transplant team, in home care and supporting satellite sites. Throughout Mike’s career he has always been focused on process improvement within clinical research and has been dedicated to giving back when possible.