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

Others Details

For more detail please click on this below link: http://bit.ly/30UOcCE Email: [email protected] Tel: +1-(510)-868-1040