Boston Professional Events List

Current issues in assuring data integrity in life sciences : 2 Days Seminar

Apr 25, 2018 - 08:00 AM - Apr 26, 05:00 PM
conference Manager
San Diego CA
Homewood Suites by Hilton San Diego-Del Mar , 11025 Vista Sorrento Parkway,

San Diego,
ZIP: 92130
Phone: 858.720.9500

Ticket Price: Seminar One Registration -$ 1395 Special Group Discount Register for Four attendees -$ 4995

Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area.  Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”.  This has resulted in the escalation of costs and it is disproportionate to the benefits gained.  Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.

Areas Covered

What is Data integrity
Data Life Cycle design and controls
Elements of a Data Integrity Assurance program
Roles and responsibilities of different groups in ensuring data integrity
What data integrity SOPs do auditors expect to see during audits
Validating Data Integrity

Who will Benefit
  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Developers of software for use in Life Sciences industry
  • Validation service providers, IT service providers
  • Manufacturing personnel, Manufacturing Automation system vendors and system integrators
  • Regulatory Affairs group, Quality Unit
  • Laboratory personnel
  • Users of Cloud
  • Clinical Trial Sponsors

Learning Objectives

Some advanced Data Integrity topics include:
         Data Integrity triad
         Data Integrity Maturity Model
         Developing critical thinking skills
         Data Integrity Audit trends 

Speaker Details

Know Your Speaker

Chinmoy Roy   BSEE, MSCS US FDA Expert Data integrity & CSV
Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems.Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.

Event Categories
Keywords: pharmaceutical , biotechnology, FD


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