2019 - Data Integrity and Compliance with GxP It’s not new and so much more than just computers

OVERVIEW
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.
LEARNING OBJECTIVES
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
WHY SHOULD YOU ATTEND
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.
AREAS COVERED
Regulations and guidance - US, EU, MHRA, PIC/s; Regulatory Enforcement – Recent Examples; Infrastructure Requirements ; Pragmatic approaches
WHO WILL BENEFIT?
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.
SPEAKER
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
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