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Dr. Daniel Tisak

Quality Director


Compliance, Quality Consulting, Regulatory Compliance
Dr. Daniel Tisak is a Quality Director with extensive experience in the pharmaceutical, biotechnology and biomedical device industries.
  • 25+ years of global experience in aeromedical, radiopharmaceutical, pharmaceutical, biotechnology and medical device industries and facilities, 15+ years in regulatory affairs.
  • Has performed audit and validation services following GXP guidelines (GAMP, GCP, GLP, GcLP, GMP). GCP and GLP activities include routine study audits, inspection of testing facilities, verification of reports, verification of Quality Assurance Unit (QAU), verification of training, SOPs, and data integrity.
  • Engineering team leader to execute $1.5 million average project backlog annually for the completion of validation, regulatory audits, project engineering and construction management, quality assurance and commissioning following multiple regulatory requirements. USGBC LEED AP, AEE Legend in Energy.
  • Proven project management ability. Written and “hands on” executed approved quality and regulatory documents for inspections of pharmaceutical facilities, devices and controls. Worked with numerous corporate teams to provide quality and regulatory evaluations and strategies. Mentor of quality assurance, cross-functional teams and team building excellence.
  • Subject matter expert and presenter, International Society of Pharmaceutical Engineering (ISPE) and the Association of Energy Engineers (AEE).

Articles by Dr. Daniel Tisak

Continuous Manufacturing of Pharmaceutical Products: The New Norm

The life sciences sector is changing for the new pharma generation with the introduction of many forms of updated technology and solutions. Continuous manufacturing (CM) is a perfect example. CM is a method for manufacturing pharmaceutical products from end to end on a single, uninterrupted production line. It uses advanced manufacturing technologies to send materials […]

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