Dan Ficker Email & Phone Number

Pleasant Prairie, Wi, Us

North Chicago, Illinois, Us

• Global R&D Data Integrity (DI) Quality System Owner (QSO)• Owns R&D GxP Data Integrity strategy including oversight development and implementation of related controls and remediation plans• Oversees Computer System Validation (CSV) activities including Digital Health Technologies• Completes computer system risk assessments, oversees development and implementation of related controls and remediation plans• Partners with the Continuous Improvement team to identify areas of risk as focus areas for the DI and CSV quality systems

North Chicago, Illinois, Us

Responsible for the strategic leadership of Software Validation program for R&D. Monitor current trends of global regulatory agencies as they apply to Validation and Data Integrity. Understand the impact of changes on other quality system, communicate the changing regulatory requirements, and drive change. Influence the decision-making process to ensure quality requirements are included when improvement initiatives take place.

North Chicago, Illinois, Us

Provide Software Quality Assurance support to the pipeline to assure computer system software meets requirements for use to ensure high quality products and data compliance with GxP regulations/ computer based systems and are validated across all phases of drug development and systems life cycle. Ensure global computer systems meet internal policy/ procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11) Drug Regulations. Provide leadership and guidance for validation related CAPA Activities.

North Chicago, Illinois, Us

Supervises the determination of a client area application systems requirements for new or modified application programs, the preparation of systems specifications and the development, testing and implementation of efficient, cost effective applications solutions. Acts as expert technical resource to development staff. Developed Testing strategy for data center server migration.

Abbott Park, Illinois, Us

Supervises the determination of a client area application systems requirements for new or modified application programs, the preparation of systems specifications and the development, testing and implementation of efficient, cost effective applications solutions. Acts as expert technical resource to development staff.

Abbott Park, Illinois, Us

Abbott Park, Illinois, Us

Responsible for mentoring and career development of 3 indirect reports. Laboratory Subject Matter Expert and Validation Lead for GPRD Systems, including Lake County/Ludwigshafen deployment of GALAKSIS 2004 Laboratory Information Management System (LIMS), GLIMS Reporter and ATLAS Chromatography Data System (CDS)/GALAKSIS Interface. Trained Lake County GPRD Support Staff for the GALAKSIS Deployments. Partnered with Thermo Electron and Abbott Purchasing to establish enterprise license agreements. Coordinated/ Led Global Abbott-wide Knowledge Sharing Group for Laboratory Systems, providing updates on services and options both internally and via vendors.

Abbott Park, Illinois, Us

Responsible for mentoring and career development of 6 direct reports and 2 indirect reports. Responsible for the 24/7 support of all GPO Laboratory Systems that provide the testing and release of pharmaceutical products including multiple LIMS and CDS solutions. Liaison with vendors and Corporate for service level agreements on Laboratory system agreements. Managed internal and vendor contract negotiations for ThermoLIMS service level agreements and license agreements to create a cost avoidance of more than $250 M. Developed the criteria to capture the Total Cost of Ownership and responsible for the total cost of ownership financials for Laboratory Systems. Transitioned to supporting all GPO Quality Systems with no disruption in client service support. Coached staff, informed clients and coordinated multiple Support Centers training to prepare for the launch of the Corporate Standard LIMS to remote Abbott Biological facilities. Defined/Refined support structure, documentation and standards to improve level of support to the customer that allowed us to increase the number of supported applications four fold while retaining the same size staff; Team Lead, LIMS and CDS (2002-2004)Responsible for career development of 4 direct reports and 2 contractors. Managed LIMS $1.4 MM Project ahead of schedule and under budget. This started as a single division system and grew into a multi-divisional system with an accelerated timeline based on regulatory compliance needs. Member of the GPO Roadmap team which co-defined the Long Range Plan and strategic vision for Laboratory systems within Quality for the division. Evaluated and selected the Corporate Standards for LIMS as member of Cross-Divisional teams. Provided detailed reports and system information as quality liaison and/ or agent in charge for Laboratory systems internal and external audit requests. Recognized by peers and upper management as an expert in the laboratory systems area.

Managed the complete software development life cycle of multiple large projects. Responsible for the deployment of CDS to the Whippany and Jayuya sites during the Knoll Acquisition to transition them from stand alone instruments to a Part 11 compliant solution. Acquired hardware, client liaison, performed user training, provided user documentation and supported the local 'Go Live' of the system. Supported LIMS, chromatography and related systems. Hardware/software resource coordination, personnel and timeline management, design, development, validation testing and implementation. Led project team and users to gather requirements, map business processes and identify opportunities for improvement. Coordinated and provided guidance to team members and assisted project management activities. Established clear project expectations and provided ongoing communications with clients and management.

Maintained and troubleshot Beckman LIMS/PeakPro Systems for QA Laboratories. Developed, validated and instituted automation projects that increased lab efficiency. Provided leadership direction to divisional IT for future Oracle database enhancements. Developed and maintained procedures/policies to support system operation and training. Trained laboratory personnel on departmental LIMS/PeakPro procedures.

Independently developed new analytical methods and presented scientific data. Designed, developed and validated Excel spreadsheets that increased the efficiency and accuracy of laboratory data. Reviewed laboratory data and evaluated procedures. Trained new employees and contractors. Published Scientific works in 1995, 1998, 1999. Analyzed raw materials and drug substances.