The quality of a service can only be measured by the quality of the provider.
Thus, we feel it's important to highlight a few of our consultants to showcase their particular breadth and depth of knowledge.
Brandi Guillemette is a seasoned Validation Lead with experience in multiple regulated industries. She joined Safis Solutions as a Senior Compliance Analyst in 2007, bringing almost a decade of IT, manufacturing process validation, analysis, and documentation experience. Guillemette’s experiences include validation and testing of computer systems for manufacturing facilities, process control software, enterprise wide IT systems, and custom software applications. Further, she is adept at creating training, user guides, and systems documentation. She has expertise across the Software Development Life Cycle (SDLC) validation process spanning from requirements definition to system retirement. Guillemette has created validation management systems for multiple platforms including SharePoint 2003 and Microsoft Access. Her testing experience includes custom software, black box and white box systems, regression, migration, and user acceptance testing. She has performed testing in multiple languages on several platforms (Ex: XP, Vista, MAC, NT) using interfaces such as Firefox, IE6 and IE7. Guillemette earned a degree from Indiana University.
Gretchen Parker, PhD, RAC (Regulatory Affairs Certified), joined Safis Solutions as a regulatory compliance analyst following 10 years of research in the fields of Biochemistry and Molecular Endocrinology. At Safis Solutions, Dr. Parker supports clients in regulatory submissions with expertise in both clinical and chemistry and manufacturing controls (CMC) regulatory. Further, she has extensive experience with USDA regulatory procedures. Finally, Dr. Parker has built quality systems for several life science clients. Previously, in her role as a federally-funded scientific researcher, her responsibilities included the development and implementation of molecular and biochemical techniques, preparation and presentation of scientific results at conferences and research seminars and organization of data for the patenting process. She has performed research in both analytical and bio-analytical labs. Additionally, Dr. Parker has extensive experience in the composition of research papers, review articles, book chapters and grant applications. All four grants submitted to the National Institutes of Health by Dr. Parker have been funded. Dr. Parker received her Ph.D. from Purdue University, is RAC certified, and is a Biologics Senior Faculty Member for the Regulatory Affairs Professionals Society.
John Steichen, RAC (Regulatory Affairs Certified), joined the Safis Solutions team in early 2007. As Senior Compliance Advisor he evaluates clients’ quality systems and GMP/GLP/GCP compliance status. He has developed quality systems for life science companies, and regularly performs GXP audits and vendor assessments globally. As a previous manager of a QC laboratory, he has deep expertise in QSR laboratory controls including qualification of systems, protocol development/execution, and data management. Steichen is skilled in product development, vendor qualification, third party organization audits, SOP implementation, and validation protocol development and execution. His 25 years of experience range from chemist to QA/QC manager and several other technical positions.
John Lockwood, CQA (Certified Quality Auditor), brings 14 years of experience in the Medical Device industry to Safis. Prior to joining Safis, Lockwood worked for Roche Diagnostics for seven years serving in a breadth of roles including Quality Control manager, Test Method Validation manager, Supplier Quality Engineer, and Purchasing manager. In addition, he worked for Abbot Laboratories for seven years in various technical support and product development roles. As a Senior Compliance Advisor Lockwood specializes in quality management systems, design control methodologies, supply chain assessments, device and diagnostic product development planning, and quality compliance. His certifications include Six Sigma Green Belt, C.P.M., and CQA.
Lisa Schuster, RAC (Regulatory Affairs Certified), joined Safis Solutions in early 2006 and serves as a Compliance Advisor. She is an experienced auditor, quality specialist, validation engineer, and CMC regulatory specialist. Schuster has developed and implemented quality systems for multiple start-up companies. She also has experience in auditing clinical trial service providers’ systems with special expertise in 21 CFR Part 11 compliance. Schuster has led all phases of validation for IT systems, software, manufacturing facilities, processes, equipment, and building commissioning. She has authored and reviewed Chemistry, Manufacturing, and Controls sections used in Investigational and New Drug Applications. Prior to joining Safis, Schuster worked for 4 years as a validation engineer in equipment qualification and computer system validation for the pharmaceutical industry. She is RAC certified and received her B.S. in Chemical Engineering from Case Western Reserve University.
Lora LaBrash is an experienced Validation Lead with experience in the pharmaceutical industry. She joined Safis Solutions as a Senior Compliance Analyst in 2007. Within the pharmaceutical industry, her experience includes creating SOPs, testing systems for multiple platforms including SharePoint 2003. Her testing experience includes custom software, black box and white box systems, regression, migration, and User Acceptance on MOSS2007 systems. She has performed testing in multiple languages on several platforms (Ex: XP, Vista, MAC, NT) using interfaces such as Firefox, IE6 and IE7. In addition to her testing and documentation experience, LaBrash has over fifteen years of training experience, including developing and delivering training for new software programs as well as sales training. LaBrash earned a degree from Ball State University
Peter Kuhns is a seasoned validation professional with experience as a validation engineer, software test analyst, and technical writer. Kuhns joined Safis Solutions in 2007. He has expertise in authoring validation documents for software and equipment, user manuals, developer guides, and technical manuals. With over 8 years of experience in the Software Development Life Cycle (SDLC), Kuhns is adept at validation documentation and all aspects of validation from requirements definition to testing to system support. Finally, he has strong testing skills and has created test plans and executed testing for software, hardware and instruments. Peter has a BA in English and Political Science from Indiana University.
Ryan White joined the Safis Solutions team in 2006 and serves as a Senior Compliance Analyst. He has experience assisting medical device, in-vitro diagnostic, pharmaceutical and biopharmaceutical clients with the establishment of Quality Systems and the creation and filing of Regulatory documentation. He has successfully audited dozens of GMP, GLP, and GCP facilities on behalf of clients. Prior to joining Safis, White worked as Manager of Regulatory Affairs and Quality Assurance for 3 years for a Medical Device Company overseeing product development, FDA submission, quality, and manufacturing. He is familiar with drafting and filing federal regulated documentation for clients.
Steve Wilson is a validation and testing specialist with unique skills in software and hardware validation in regulated environments. Prior to joining Safis Solutions in 2008 as a Compliance Analyst, Wilson had over 10 years of regulated industry experience in validation, testing and technical writing for the life science industry. Steve has held roles as a software validation and hardware qualification engineer, quality analyst, test lead, copy editor, technical writer, and document management librarian. Wilson's areas of expertise include validation, software testing, IQ/OQ/PQ, SOP creation, technical writing, website development, and user guide development. Wilson attended the University of Cincinnati and received an Oracle Database Administration certification from IUPUI.
Tamara Beall, CSQA (Certified Software Quality Analyst), joined Safis Solutions in 2005 as a Senior Compliance Analyst. Her extensive experience in system validation, software testing, technical writing, and document production makes her a valuable part of our staff. She also has specialized experience in FDA-compliant computer system validation (CSV). Prior to joining Safis, Tamara had experience working as a quality consultant, test analyst, marketing and technical operations coordinator, and consulting analyst. Tamara's broad work experience is complemented by her regulatory expertise in 21 CFR Parts 11 and 820.
Usha Srinivasan, M.S., RAC (Regulatory Affairs Certified), is a Senior Compliance Advisor at Safis Solutions. In her role, she provides expertise for global regulatory affairs strategies for pharmaceutical drugs, bilogics, devices and diagnostics. Srinivasan has 16 years of experience in life sciences product development. At a large life sciences company she held multi-disciplinary roles ranging from basic research, business development, due diligence, bioproducts strategy, Six Sigma black belt, and global regulatory affairs. She is a qualified and seasoned project manager who is able to lead across the functional expertise areas required for product development. She has led the assessment of licensing opportunities to enrich life science company’s portfolios. Srinivasan has experience in developing regulatory strategies for several drug and device regulatory filings. With a Master’s degrees in both biochemistry and molecular biology, she is able to apply her scientific knowledge to novel biomarkers, pharmacogenomics, diagnostics, devices, and drugs. Srinivasan is also a member of ASQ, DIA, and RAPS associations.