Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11

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San Diego

San Diego, CA 92101

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Event description
The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significan

About this Event

Learning Objectives:

  • Understanding what data integrity is
  • Why data integrity is a focus by Health Authorities
  • Understand that data integrity is not now - the concepts behind 21CFR Part 11
  • Establish the relationship between company culture and data integrity
  • Understand how data integrity relates to computerized system implementation and usage
  • Applicability of data integrity to legacy systems
  • Relationship between print outs and meta data
  • How to conduct a data integrity risk assessment
  • How to audit for data integrity issues
  • How to mitigate data integrity risk
  • How to remediate data integrity issues

Areas Covered :

  • Regulatory basis for data integrity enforcement
  • Cultural basis for data integrity issues and difficulty to effect culture change
  • Assessing data integrity risk and mitigation
  • How to audit for data integrity issues
  • How to remediate

Speaker :

George Bernstein

Principal, Double Dragon Consulting, Inc.

George Bernstein, Ph.D., is a Principal with Double Dragon Consulting, Inc., a consulting firm with a network of Subject Matter Experts located in the US, Europe, and Asia Pacific (China, India). Dr. Bernstein has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured on quality systems and root cause analysis to industry trade groups, quality organizations, and at Interphex. In 1998, Dr. Bernstein led the development, validation, and implementation of an electronic batch record system for a client. This system is still in use today.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

For Registration :

https://www.complianceonline.com/fda-data-integrity-seminar-training-80614SEM-prdsm?channel=eventbrite

Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

Date and Time

Location

Hotel To Be Announced

San Diego

San Diego, CA 92101

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