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

Date : 16th October 2019 to 16th October 2019

Place : United States, Newark

Website :http://bit.ly/2VvBM3c

Contact Person:+1-(510)-868-1040

Description:

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 For more detail please click on this below link: http://bit.ly/2VvBM3c Email: [email protected] Tel: +1-(510)-868-1040

Data Integrity and Compliance with GxP It’s not new and so much more than just computers will be held in Newark,United States on date 2019-10-16

---

Deadline for abstracts/proposals : 16th October 2019

Keynote Speakers :

Venue :Online

Check the event website for more details.