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David P. Buynak

CA Regional Manager, Compliance

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"Success is not final, and failure is not fatal: it is the courage to continue that counts."

David has over 30 years 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 & distribution, compliance auditing, validation planning/execution and preparation of regulatory documentation for the US and global agencies.

David spent 12 years developing and executing progressive serialization strategies to meet traceability legislation in North America, South America and in the Asia-Pacific region where he was responsible for ensuring serialization adoption plans were developed and executed to meet legislative traceability requirements. David was accountable for overall success of the regional supply sites to achieve compliance, ensure market access and manage site capital budgets.

  • B.A. - Biology, Gettysburg College
  • Manufacturing Professionalism Programme, University of Warwick (UK)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Parenteral Drug Association (PDA)
  • Project Management Institute (PMI)
  • AstraZeneca Pharmaceuticals
  • US Bioscience, Inc. (now part of AZ)
  • Rhone Poulenc Rorer Pharmaceuticals
  • Buynak, David. “The Track to Serialization: Solutions to Safeguard Your Products.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2018, 18 February 2018.
  • Buynak, David. “Serialization.” IPS SoCal Biopharma Lecture Series, 5 October 2017, Irvine, CA.
  • Buynak, David. “US Traceability Requirements: How Close Are You to Meeting Them?” IPS SoCal Biopharma Lecture Series, 31 August 2018, Irvine, CA.

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