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About QACV

 

QACV was founded in 2001 and has provided quality assurance, compliance, and computer validation services to the life sciences industry for over 16 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.

  • 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., QACV Consulting

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. Chris Wubbolt CV.pdf

 

Aida Markham, Vice President, Compliance

Aida is a Certified Quality Auditor (CQA-ASQ) and Certified Quality Engineer (CQE-ASQ) with 20 years of experience in quality assurance. She has been providing consultancy services through QACV since 2011 where she has primarily focused on leading and conducting quality assurance, training, and audit activities and teams. Aida’s prior experience includes working with small and mid-size biotech, medical device, and pharmaceutical companies such as Opera Therapeutics, Stryker Endoscopy, Watson Pharmaceuticals, as well as with CROs where she led the development and monitoring of quality management, training, validation, risk management and regulatory compliance programs; auditing, audit preparedness and audit remediation; the development and maintenance of document management systems; and computer systems validation. Aída has a BS in Industrial Engineering and is pursuing a Masters Degree in Quality Assurance and Regulatory Affairs. She also holds Quality Engineering (CQE) and Quality Auditor (CQA) certifications.

Noreen Muscat, Senior Consultant

Quality Assurance/Regulatory professional with over 18 years of experience in the Pharmaceutical/Biotech and Medical Device Industry. She had ownership of Quality Systems and Validation/Governance in positions of increasing responsibility. Her vast industry cross functional and GAMP experience led her to be the Quality System SME for previous FDA and EU audits. She has successfully implemented, validated and launched many electronic technologies for both large and small companies with an emphasis on training, safety, compliance and validation. She has participated in many FDA inspections and audits with no warning letters issued.

Successful Implementations- Role:

o   Small to Midsize Pharmaceuticals LMS Validation project lead (75+ validation projects with UL EduNeering clients)

o   Mid-size Pharmaceutical 500+- Validation and Governance Support

o   Mid-size Pharmaceutical company 400+ System Owner- Regulatory and Quality

o   Large global Pharmaceutical company 5000+ Global Business Lead, Regulatory and Quality

o   Small Pharmaceutical 200+ System Owner- Regulatory, Clinical, Quality, and Information Services

o   Large Global Pharmaceutical/Biotech 8000+- Regulatory, Clinical and Quality

Sharon Strause, Senior Consultant

Sharon has been a consultant since 2004 to the LifeScience, Consumer Product, and Software Development Industries.  She does consulting in the areas of Quality Assurance, Quality Control, Computer System Validation, Clinical, and Quality Documentation practices for QACV Consulting, LLC.

 

Previous to her consulting, she had 15 years experience working for a Johnson and Johnson Company.  Sharon worked for 7 years in the Quality Assurance Division managing the Document Control Group which established standards, policies and practices for documentation.  For 8 years, she worked in the Operations Department and Information Technology departments on SAP validation and establishing best practices for computer system validation.

 

Sharon has developed several training courses on Computer System Validation, GMP training, testing, and “train-the-trainer”.  She led the SAP Validation Networking Group, which was part of the SAP America’s User Group, for 6 years.  She is a member of the ASQ organization and served on the advisory board of the Institute of Validation Technology for 10 years.

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

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