Alisa Benson Email & Phone Number

Greater St. Louis

Greater St. Louis Area And Smyrna, Tn

Leading a team of 3 Sr. Specialists and 2 Coordinators, this team carries the responsibility for Regulatory compliance in Health-Canada-regulated OTC drug and cosmetic products, FDA-regulated OTC monograph drug and cosmetic products, EPA-regulated pesticide products, CPSC-regulated consumer products and OSHA-regulated industrial products. (EPA/CPSC/OSHA are new areas to Vi-Jon so we are managing through consultants but must maintain a working knowledge of each Agency’s requirements). Team responsibilities include:Food and Drug Association and Health Canada:• Safety and efficacy testing conducted by a third party lab.• Development of required verbiage and acceptable claims to be used on all products.• Record keeping and maintenance of product files.• Drug listing of house brands and for private-label customers.• Voluntary cosmetic listing as requested by customers.• Maintain approved product titles and product number assignment.• Maintain Kosher status and recordkeeping on applicable drug items.• Maintain American Dental Association approved status and recordkeeping for house brands and private label customers.• Review of all promotional materials.Environmental Protection Agency:• Annual reporting required by the Agency.• Maintain application.• State registration of all pesticide products.• Review of promotional materials, provide guidance.• Submit notifications/amendments to EPA as needed.• Prepare and submit response for data call-in requests.Consumer Product Safety Commission:• Safety testing conducted by a third party lab.• Development of required verbiage and acceptable claims to be used on all products.• Occupational Safety and Health Administration:• Safety testing conducted by a third party lab.• Development of required verbiage and acceptable claims to be used on all products.• General Responsibilities:• Review of all artwork for all products produced on-site and by contract manufacturers.• Respond to customer inquiries.

Continuously develop interesting methods for delivery of class materialCreate useful tools for students to refresh or acquire basic Anatomy and Physiology. They may be viewed at www.alisabenson.comPrepare students for the National Board Certification Exam for Massage TherapistsMember of Human Anatomy and Physiology Society2009 - Faculty Member of the Quarter2010 Honorable Mention - Master Teacher Award sponsored by ABHES and Elsevier

• Provides input to external and internal partners on NDA/ANDA labeling and promotional materials corresponding to FDA requirements.• Self-taught in .xml coding. Reduced budgetary requirements by $12,000+ annually by learning to create/edit structured product labeling files for drug listing, labeler code requests and establishment registrations – No software beyond the FDA starter kit required!• Provides assistance in the generation, review and submission of product labeling to global regulatory authorities as needed.• Reviews and approves clinical trial and developmental batch labeling.• Department representative on the change control committee and project teams to review all labeling changes for regulatory impact prior to approval for implementation.• Created/Implemented electronic tracking to facilitate querying information for use with internal and external clients.• Assist in process improvements in the Production and Quality areas. Member of Drug Information Associatioin

Assisted with trainingLabeling maintenanceCompiled label historiesDrafted cover letters and appropriate formsAssembled submissions to FDACoordinated production printing with the manufacturing facilities and print vendors

Assisted with trainingLabeling maintenanceCompiled label historiesDrafted cover letters and appropriate formsAssembled submissions to FDACoordinated production printing with the manufacturing facilities and print vendors

Supervisory experience:• Coordinated the day-to-day functions for the Operations Support Team, which consisted of four departments (Pre-Labeling, Vial/Stopper Prep, Staging and Label Control) and 28 individuals.• Ensured all departments were in compliance with all regulatory agencies and training records were up to date.• Authored new Standard Operating Procedures, routed for approval, and implemented the changes.• Served as interim Production Superintendent of the Operations Support Team.Project management experience:• Led two teams to determine process improvements for the training system and lead inventory system at the Maryland Heights, MO facility. Six Sigma Green Belt Certified, trained in 5S and Lean Manufacturing.• Created bar-coded system to track inventory real-time. This project saved $80,000+ in waste and lost product.• Significantly reduced encoding errors on product labeling by implementing bar code based on-demand printing system.• Developed through experimentation and validated a new process for depyrogenation of all stoppers which eliminated the use of harsh chemicals and boiling of stoppers.• Initiated development of a web-based system of querying MSDSs searchable by product name, manufacturer, chemical formula or internal product code for fast access in case of emergency. • Developed and implemented a plant-wide training system.• Created trouble-shooting manuals on the intranet to assist users when common errors occur on the production lines.