2021 - Data Integrity: FDA/EMA Requirements and Implementation

Day 01(11:00 AM - 5:00 PM EDT)
11.00 AM: Session Start
Introductions
Instructor
Participants
Determination of participant’s desires and expectations for the session
Introduction to data integrity
Defining data integrity
“ALCOA” acronym meaning
Criticality of data integrity to “GXP”-governed activities
“Fraud” versus innocent conduct that can lead to data integrity lapses
Examples from other industries (automobiles, finance, etc.)
Historical Perspectives
The American “Generic Drug Scandal” of the late 1980s- early 90s and its consequences
Expansion of computer system use in GXP operations and its impact
Emergence of current worldwide concern among regulators
Motivators behind deliberate wrongful conduct
“Achieve gain”
“Avoid pain”
Managing to avoid the “Law of Unintended Consequences”
Computer system issues
Audit trails
Changes to data
Metadata implications for data integrity
Computer System Controls required by the US and EMA
FDA Case studies of data integrity issues
GMP
GCP
GLP
Day 02(11:00 AM - 5:00 PM EDT)
Welcome and time for questions from day one
Comparison of current data integrity guidance documents from regulators and industry sources
FDA
EMA
PDA Code of Conduct (industry viewpoint)
PIC/S (Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme)
Consequences of noncompliance
FDA:
Application Integrity Policy
Disqualification of Clinical Investigators
Civil and criminal sanctions
Case study: Consent decree imposed on a company outside the US; implications of extraterritorial jurisdiction asserted by FDA
EMA/MHRA
Other agencies
Business consequences – Case study examples
Steps to take to prevent, detect and react to data integrity problems
Fundamentals of good documentation practice
Retention of true copies in lieu of originals – is it allowed, and if so, what are the expectations?
Signs you may have a data integrity problem
How to react if you suspect deliberate falsification
Involving legal counsel and external expert assistance
Considerations for voluntary disclosure to regulators (with concurrence of legal counsel)
Questions, general discussion, summary and wrap up