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The Track to Serialization – Solutions to Safeguard Your Products

| 7:00 p.m.

The Serialization Tour focuses on pack line and warehouse devices as well as software solutions to meet US and global traceability regulations. You will hear from industry thought leaders about the impacts, technical challenges, and potential benefits beyond compliance of serialization implementation.

  • David Buynak

    David Buynak

    Regional Compliance Manager, Serialization Specialist

    David has over three decades of experience in a variety of strategic and technical positions in the pharmaceutical industry within manufacturing, technical services, regulatory affairs, quality assurance and product security supporting aseptic, solid oral dosage, and blow-fill-seal facilities. His background includes project management, strategic development, packaging and distribution, compliance auditing, validation planning/execution, and preparation of regulatory documentation for US and global agencies. David spent the previous 12 years developing and executing progressive serialization strategies to meet traceability legislation in North America, South America, and the Asia Pacific region for AstraZeneca Pharmaceuticals.
    David has over three decades of experience in a variety of strategic and technical positions in the pharmaceutical industry within manufacturing, technical services, regulatory affairs, quality assurance and product security supporting aseptic, solid oral dosage, and blow-fill-seal facilities. His background includes project management, strategic development, packaging and distribution, compliance auditing, validation planning/execution, and preparation of regulatory documentation for US and global agencies. David spent the previous 12 years developing and executing progressive serialization strategies to meet traceability legislation in North America, South America, and the Asia Pacific region for AstraZeneca Pharmaceuticals.
  • Kevin Swartz

    Kevin Swartz

    Senior Engineer, Packaging

    Kevin is an innovative senior engineer with hands-on experience in packaging machine design, line integration and commissioning, and project management in pharmaceutical and near-pharma environments. He has a proven record of developing technical solutions within team environments for the design, manufacturing, and operation of packaging equipment. He has held leadership roles in both OEM and end-user organizations. His experience in the packaging and pharmaceutical industries includes design of labeling and thermoforming equipment, servo motion profile development, Datamatrix and RFID serialization implementation, rapid changeover, cGMP lifecycle documentation generation (FRS/DDS/URS/FAT/SAT), as well as finding and eliminating process waste using lean tools and techniques.
    Kevin is an innovative senior engineer with hands-on experience in packaging machine design, line integration and commissioning, and project management in pharmaceutical and near-pharma environments. He has a proven record of developing technical solutions within team environments for the design, manufacturing, and operation of packaging equipment. He has held leadership roles in both OEM and end-user organizations. His experience in the packaging and pharmaceutical industries includes design of labeling and thermoforming equipment, servo motion profile development, Datamatrix and RFID serialization implementation, rapid changeover, cGMP lifecycle documentation generation (FRS/DDS/URS/FAT/SAT), as well as finding and eliminating process waste using lean tools and techniques.
  • Adents
  • ANTARES VISION U.S.A.
  • METTLER TOLEDO Product Inspection Division
  • Optel Vision
  • WIPOTEC-OCS, Inc.

Tours are held on Wednesday, April 18, 2018, at 10:00 a.m. and again at 1:00 p.m., and typically run two hours long. Registration does not guarantee admission to the Tours and will close on Friday, March 30, 2018.

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