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.

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/.

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.

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.

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.

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.

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.

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.