Coda Corp USA primarily services Quality and Operations Systems, assessing, developing and implementing quality systems, validating manufacturing processes but also provides general compliance consulting.Ms. Guido-Redden founded and continues to lead Coda’s Quality Services and Regulatory Compliance divisions. In this capacity, she provides expertise toward compliance with cGMPs, GCLPs, GLPs and GCPs: Title 21 CFR, parts 600, 601, 610, 820, 210, 211, and 11, ISO and DEA regulations. Ms. Guido-Redden oversees all client projects for quality, efficiency, and technical accuracy; providing Senior Leadership to all active projects and supplementing Sr. Leadership of client organizations. Specialties include leading client manufacturers through complex remedial activities or dynamic change and providing global interpretation of regulatory expectations.

ACM Global LaboratoriesAllerganAMETEK/Reichert APP PharmaceuticalsApplied Biosciences, SQL LIMS Preferred Service PartnerAthenexAventis Banner PharmaceuticalsBausch & Lomb Baxter HealthcareBeckman Coulter, User Wish List Committee Chair and Preferred Service PartnerBiokitBristol Myers Squibb Buffalo Niagara EnterpriseCaliber, Imaging and DiagnosticsCanisius College; The Women’s Business CenterCarestream HealthCellTech Manufacturing Clerio VisionCognivueConax TechnologiesCoopervsionCresilonEndo PharmaceuticalsEthox InternationalFox Pharmaceuticals Contract Manufacturing Fresenius KabiGAMP, Part 11 White Paper Committee MemberGreatbatchHauptman-Woodward InstituteHeanyHoffman-LaRoche Hospira PharmaceuticalsHyde Engineering IMMCO DiagnosticsImmunex ImmunoTherpeautics, IRXInnovation Center - Buffalo Niagara Medical CampusIuvo BioscienceJ & R ConsultingJ&J, Centocor J&J, Ortho – Clinical Diagnostics Kinex PharmaceuticalsLabVantageLeitersLucid TechnologiesMaster Control, Enterprise Partner and GxP LifeLine Columnist/BloggerMerck and Co., MMDMerck and Co., MRLMicro Systems EngineeringMonsanto Moog Medical DevicesNextArrowNinaza, Clinical Application Developers for CROs NOVA Century ScientificNovartis Ortho Clinical Diagnostics, a J&J CompanyPall Life SciencesParke-DavisPastuer Merieux ConnaughtPatheon, Contract ManufacturingPfizer PharmaNova PharmaceuticalsPUMAS AIQualPak, Contract Packaging Quintiles ConsultingReichert Technologies/AmetekRhone Poluenc ROC IT SolutionsSanofi PastuerSigma Pumps InternationalSparta Systems, Preferred Service PartnerStiefel Laboratories Straight Forward ConsultingTEDxBuffaloThe Life Science LinkThermo FisherTrinity BiotechTunnell ConsultingUnited TherapeuticsUnither ManufacturingUniversity of RochesterUnited States Food and Drug AdministrationViewRayWarner-Lambert Watson Pharmaceuticals Wyeth-AyerstZoll Medical

A professional program that accepts established business owners and partners them with professional coaches who are successful business owners and professionals and leaders in their respective areas. The program is designed to offer guidance, mentorship and coaching to small business owners in order to help them grow their business or practice locally, regionally and nationally. Coaches are selected based on their leadership abilities, business management success rate and field(s) of operation. Coaches are extensively trained and provide structured guidance to enable the advancement of the defined goals of program participants.

Dedicated to promoting the growth of the Life Science Industries within the Buffalo/Niagara region, the LSL leverages existing relationships with established organizations to seed the continued growth of this sector within our local economy.The Life Science Link is an experienced and expert business development team dedicated to creating and developing new business opportunities, and to improving the operating performance of established companies in the Life Sciences industry.The LSL connects researchers, industry executives, business development professionals, investors, and service providers in a way that promotes growing markets, guides new products and technologies through the commercialization process; ensuring the successful creation, development, and growth of emerging Life Science companies.Comprised of a team of regional industry leaders and functional experts; the LSL partners offer skills needed to face any type of challenge that emerging organizations may face; including protection of intellectual property, business creation and profit optimization, process design, regulatory navigation and resource development. The Life Science Link provides a broad spectrum of solutions to meet a wide variety of requirements.

Validation Department management, Project management, design, execution and reporting of Quality Software and Hardware Qualifications. Technical writing – Validation Plans, User and Functional Specifications, protocols (IQ/OQ/PQ), reports and internal procedures. Adherence to CGMPs, Title 21 CFR, parts 820, 210, 211, and 11, ISO and DEA regulations.

Facility and Process Validation; project/team management, project planning and problem solving, purchasing, scheduling. Design, execution, reporting of Control , Cleaning, Operational (equipment) and Process (manufacturing/packaging; liquid and solid), Utility/Facility (PW, OFCA, HVAC) Qualifications. Technical writing. GMP and DEA regulations, clean room experience.Global Automation; system configuration and implementation, hardware and software validation, technical writing - protocols, reports, OPs, SOPs (system operation, system management and training), training and user manuals, monthly newsletter. Developed and administered LIMS user training program, and ‘LIMS to Lab Outreach’ program providing users technical support and continuing computer education.R&D; method development, participation in patented research projects, independent synthesis of experimental organic compounds, analysis of samples, adherence to GMP regulations, and communication of status to production groups.

Engineering and Research Division: NMR Small molecule elucidation, molecular characterization, and magnetic field alignment and report generation.