John Wall Email & Phone Number

Cincinnati Area, KY

Consultant providing Information Security Management System design * Controls Assessments * Risk AssessmentsComputer System Validataion * GXP Computer Validation Services. Policies, SOPs, Master Plans, IQ, OQ, PQ scripting and executionhttp://www.linkedin/company/cyberfit

Cincinnati, Ohio Area

Management of and Consulting on Corporate Information Security Policies.Created, refreshed, assessed second line of defense for centralized global information security policies and controls standards. Refreshed within 12 months Information Security Policy and Standards. Owned integrated Information Security controls into the IT Policies and Standards..

Cincinnati

Manage the global implementation of SAP QM in Fabric Care and Home CareLed the global household care business unit to implement an SAP/QM/BM in 53 manufacturing plants. Directed a team of regional leaders on how to design and deploy SAP batch management and SAP quality management module in manufacturing plants. Served as program manager leading.

Cincinnati Metropolitan Area

Senior Project Manager - Consultant - assisting clients with project management, business analysis and quality assurance needs.Guided global design, development and implementation of consumer web site marketing initiatives. Led design and execution of product claims approval software system.

Cincinnati, Ohio, United States

Project ManagementRegulatory Business SystemsRegulatory Operations Business AnalystRegulatory Publishing and Document Management Specialist.Knowledge Management SpecialistStructured Product Labeling (SPL) Process ExpertTest script design, analysis, review and approval

• Responsible for defining what compliance to 21 CFR Part 11 meant, leading the organization compliance efforts, and overseeing compliance.
• Led a cross functional team (IT, Clinical Data Management, Clinical Operations, Regulatory) to define the business impacts of the FDA guidance for “Computerized Systems Used in Clinical Investigations” ensuring.
• Defined the quality system for Part 11 compliance, integrated it into the R&D quality process and changed the committee’s focus from compliance oversight to new FDA guidance and regulation.

Mason, Ohio, United States

• Accountable to Regulatory Affairs for the Pharma R&D Electronic Documentation system.
• Drove upgrade and simplification projects and maintained compliance, and reliability of the Documentum based system used to build and archive product dossiers.
• Reduced support costs by approximately $1.5 Million by strategically choosing the upgrades necessary which reduced overhead costs
• Coached IT and business resources as they became familiar with the compliance SOPs that assured regulatory needs were met resulting in a more capable and efficient team and making resources available for other projects.
• Worked with business functions (Clinical Data Management, Drug Safety, Bioanalytical, Regulatory, Clinical Operations, CMC QA and IT) to design and implement processes to classify electronic documentation.
• Maintained the knowledge base data model, data dictionaries and procedures related to updating content resulting in an expanded use of the system and a reduction in the use of paper records.

• Represented Regulatory Operations on the committee.
• Led the timely completion of the Regulatory Operations ER/ES “Functional Compliance Plan” bringing computerized systems into compliance.
• Provided input into improving SOPs ensuring FDA software quality requirements were met.

• Reporting to Regulatory Affairs, led a project team with IT to analyze new software revisions and update training and work processes. These efforts enabled the business to meet changing regulatory needs, take advantage.
• Redesigned related work processes and implemented changes to systems, in response to management’s decision to outsource major submissions to lower operating costs (eliminate 4 FTEs) and improve capability to handle the.
• Provided first line support for 10 Publishers and Dossier Managers for the “always on time production” of Marketing Applications in the USA, Canada and EU.
• Test Script design, analysis, review, and approval

• Webmaster - Pioneered the use of the intranet for the Cincinnati site. Lead the North Intranet Team in developing Intranet Standards. Lead a team from Human Resources and Communications to design and rollout the.
• Web Developer - Pioneered the use of web development tools for the Cincinnati Intranet. Primarily: FrontPage 97, 98, 2000. Visual Interdev, VBScript, JavaScript. Developed a variety of static and dynamic pages.
• Client Server Developer - Selected to customize the first Visual Basic application for the Cincinnati Site. The software automatically distilled Microsoft word documents into PDF document and cataloged the file related.

• Computer Systems Regulatory Specialist. - Responsible for auditing, counseling and advising on the development, deployment and maintenance of regulatory compliant systems (laboratory automation system, Electronic Batch.
• Wrote all life cycle documentation reports (Definition, Analysis, Design, Construction and Implementation).
• Successfully completed the Validation Master Plan. Standardized Oracle installations, SQL*NET configurations, and database creation procedures.

• System Implementation Coordinator - for the Laboratory Data Acquisition computer system.
• Accountable for the successful implementation of Global LAS for the Cincinnati site.
• Developed Computer System and Telecommunications Specification for the implementation and support of computer systems for the manufacturing and Research laboratories. Coordinated and developed a quality system process.
• Coordinated the capital, $1 million, for all computer and telecommunications purchasesComputer Validation Leader for the Global Laboratory Data Acquisition Project Team. Provided leadership for the definition and.
• Assigned as the project leader to spearhead an effort to migration business critical laboratory applications from Hewlett Packard computers to Digital Equipment VAX computers;
• Responsible for selecting and implementing the training of analyst using 4GL application development environment and Oracle Application development environment;

• Senior Software Analyst for the systems/operations department providing support service for laboratory automation. Responsibilities include the support for computer and telecommunications hardware, system software.
• Participated as a key member of the client's coordinating committee responsible for the evaluation and selection of future hardware and software for laboratory automation, including the purchase of systems for.
• Performed the system management function resulting in over 99% up-time of four networked Hewlett Packard computer systems controlling over 130 automated instruments, on a 24 hour a day seven days a week schedule for a.