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Discussion of requirements for operational excellence to ensure data integrity. Presentation includes major regulations and key operational requirements for systems that ensure data generated whether in paper or electronic form maintain their integrity and reliability throughout their lifecycle. 

  • Understand that data integrity is not a new concept 
  • That requirements are so much broader than laboratories or computer generated data. 
  • Understand the results of lack of data integrity
  • Examine Pragmatic options for compliance 
  • Learn minimum Quality Management System needs to ensure data integrity throughout the data life cycle

Regulatory Agencies have been placing an increased emphasis on enforcement of data integrity. Too often companies have approached this increased enforcement as the regulators are enforcing new regulations and the issues are associated only with the laboratory.

Regulations and guidance - US, EU, MHRA, PIC/s; Regulatory Enforcement – Recent Examples; Infrastructure Requirements ; Pragmatic approaches

All members of quality organizations from VP to front line operations; Members of senior management responsible for establishing and enforcing data integrity policies, procedures and controls.

  • Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs.  Last 18 years as a consultant to biopharma, pharma and device industries.
  • Experience has spanned from R&D to Commercial Manufacture
  • Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species. 
  • Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.  
  • Expert level in Compliance and Quality System development.
  • Executed numerous Data Integrity assessments and remediation projects worldwide.
  • Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.

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