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GDWollenbe@aol.com

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Seeking to provide clients with services utilizing the following skill sets: integration and implementation of regulated industry business unit practices into computerized systems (e.g., LIMS, TrackWise™, Chromatography data systems), implementation of process analytical technology (PAT) for determination and control of CMC elements, TrackWise™ Administration and configuration of Quality System elements, validation of systems and instrumentation for use in a regulated environment, business unit end-user training in usage of systems in business environment, Quality Unit responsibilities for IT and laboratory operations.

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Experience:      

                           Extrinsic, LLC:  Independent Consultant  (April 2008 – June 2008)

·   TrackWise Version 7.0 System Developer for implementation of a Proof of Concept computerized Supplier Initiated and Client Initiated Change Control system for a medical device manufacturer.  Involved development and configuration of the computerized Change Control system in accordance with documented user requirements, development of System Lifecycle documentation, and end user training.

The Quantic Group, Ltd.:  Independent Consultant  (March 2000 – Present)

·   Performed as TrackWise Versions 6 and 7 System Developer and Administrator, as well as provide training and help desk support for client personnel before, during, and after system ‘Go Live’.  Developed TrackWise based end-user Computer Based Training modules using Global Knowledge OnDemand Developer application.   Created post-release Change Control requests and implemented changes (application and Coordinator configuration) based upon user requests stemming from initial use of the system.

·    Responsible for formulation of pharmaceutical client’s global (corporate) policies and procedures for Computer Validation/Instrument Qualification.

·   Provided third-party compliance review and approval of computerized laboratory instrumental and information management system protocols and procedures for pharmaceutical client under consent decree.

·    Responsible for development of System Lifecycle validation documents (i.e., Validation Plans, Requirements Documents, Design Specifications, Functional Work Designs, IQ, OQ and PQ procedures, Test Scripts, SOPs, Training presentations, and Job Aids), execution, and implementation of a 21 CFR Part 11 compliant event trending and tracking systems (i.e., TrackWise^TM) for multiple clients in consent decree environments to address Investigations, CAPAs (Corrective Action, Preventive Action), and Change Control.  Tasks performed and documentation generated in compliance with client’s procedures and guidelines.

·    Subject Matter Expert liaison between Quality Control Laboratories, Microbiological Laboratories and Information Technology groups to ensure that the Laboratory Investigation business practices were properly implemented within a computerized event trending and tracking system (TrackWise^TM).  This involved providing explanation of business practices to IT personnel, translation of business unit SOPs into User Requirements and optimization of these laboratory practices and procedures for migration from a paper-based system to a computerized system.

·    Responsible for creation of Standard Operating Procedures (SOPs) and Training Aids for the enterprise-wide Laboratory Compliance Enhancement & Standardization applications/systems, composed of LabWare Laboratory Information Management System (LIMS), Waters Empower Chromatographic System, and SSI CyberLab (now Agilent) Data Archival System. 

·   Auditor of client IT and laboratory computer systems, operations, and procedures for compliance with current good practices and regulatory expectations.  Focus included configuration management and change control for existing systems, and activities related to new system introduction, qualification/validation, and commissioning.

·   Third party reviewer of manufacturing Batch Record records and analytical results to assess product quality impact in accordance with CMC submissions.  Proposed recommendations to ensure compliance with CMC submissions and current Good Practices (i.e., cGMP, cGLP, cGALP).

S2I, LLC:      Principal Owner – Director: Sensors & Compliance  (February 1999 – Present)

·   Co-founder of an advanced analytical technology integration company, with emphasis on multivariate systems, optical and sensor arrays, and System Lifecycle Validation documentation.

·   Provide guidance to clients in implementation of Process Analytical Technology under current regulatory risk-based approach (i.e., PAT role in a Quality by Design [QbD] approach), necessary for the determination of critical CMC elements (i.e., Critical Quality Attributes and Critical Process Parameters).

·   Responsible for the creation of System Life Cycle (SLC) Validation Documentation sets for computer based process and laboratory instrument systems targeted for use in a regulated industry (Near Infrared, FT-Raman, Mass Spectrometry, Microwave moisture assay, Particle Size analyzer).  Documentation developed both for instrument vendors and clients wishing to use instrumentation lacking vendor supplied SLC documentation sets.  Provide support to clients in execution of qualification protocols to establish validated state.

Merck Manufacturing Division Process Analytics, Merck & Co., Elkton VA 22827

Senior Project Chemist (August 1997 – February 1999)

·   Evaluate, then implement, process analytical technology (e.g., sensors, instrumentation, and method development) for in-line and at-line determination and control of critical CMC elements in manufacturing processes, which included NIR fermentation nutrient monitoring and powder filling line verification.

Merck & Co., Merck Research Laboratories (MRL), West Point, PA  19486

Senior Research Chemist (February 1992 - August 1997)

·   Responsible for the development, design, documentation, implementation, validation, maintenance and system management of a VAX based chromatography system in a regulated industry for four (4) international facilities, including the data and results transfer pathway between the chromatography system and a LIMS system.

     Responsible for providing chromatographic system technical support, end-user training, and development of chromatographic instrument qualification procedures, for the Method Development, Quality Control and Pharmaceutical Analysis and Control (PAC) units of MRL.

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Publications and Presentations

 Glen Wollenberg, Bruce Buchanan, and Eric W. Richmond, "An Organized Approach to Instrument System Validation", Pittsburg Conference March 12-17, 2000, New Orleans, LA.

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