2-Day Virtual Seminar by Ex-FDA Director

Data Integrity: FDA/EMA/TGA Requirements and

Implementation
By: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

Dates: July 14-15, 2021 (11:00 AM to 5:00 PM EDT)

Location: Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

SPEAKER
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

His career includes 23 years with the FDA and over 21 years in GMP and
GCP consulting worldwide. In his consulting practice, Mr. Chesney helps
clients prevent quality and compliance problems through proactive
assessment and planning, and when necessary, with remediation
planning and health regulatory authority communications.
Until recently, he served as Vice President, Strategic Compliance
Services for PAREXEL Consulting, a business unit of PAREXEL
International LLC. Prior to joining PAREXEL Consulting in 1995, Mr.
Chesney served 23 years with the FDA, where he advanced from
Investigator to Supervisory Investigator and Director, Investigations
Branch, working in the Boston, Seattle and Philadelphia District Offices.
In 1991, he was appointed the District Director, FDA San Francisco District Office, where
he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance
Consulting group, and also personally provided regulatory enforcement related consulting
services to the pharmaceutical, medical device and biologics industries, plus technical
assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's
degree and postgraduate credits in biology from California State University, Northridge
and San Diego, and received a Certificate in Health Care Compliance from Seton Hall
University School of Law.

LEARNING OBJECTIVES
Upon completing this course participants should:

 Understand the meaning of the term “data integrity” and the importance of the acronym “A.L.C.O.A.” to regulatory agencies
 Understand the difference between innocent lapses and deliberate wrongful conduct
 Be aware of some of the key historical events that form the basis for regulators’ concerns about data integrity
 Understand some of the common motivations for deliberate wrongful conduct that results in data falsification
 Understand the impact of the use of computer systems on the maintenance of data integrity, and what types of system controls are mandated by various agencies
around the world
 Be aware of the possible business and regulatory consequences of noncompliance
 Understand the important steps to take to prevent, detect and react to data integrity problems

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 2-Day Virtual Seminar by Ex-FDA Director
02
DATA INTEGRITY: FDA/EMA/TGA REQUIREMENTS AND IMPLEMENTATION

COURSE DESCRIPTION
The integrity of data generated in support of marketing authorizations and in GMP, GCP
and GLP regulated activities is foundational to sound decision making and regulatory
compliance. Data integrity lapses are among the most serious concerns that
pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a
business standpoint, and in extreme cases can even impact individuals who are held
responsible for the occurrence of data integrity problems. In recent months the topic of
data integrity has been in the forefront of concern among worldwide pharmaceutical
regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting
forth their requirements and expectations for the maintenance of data integrity, as has at
least one leading industry organization (PDA).
The use of computer systems in virtually every aspect of data acquisition, storage, and
analysis can help preserve data integrity and reduce or eliminate many errors, but the
same technology can also create unique problems that must be prevented and managed.
In this two day workshop conference you will learn the meaning of "data integrity"; be
exposed to some of the history that influences current regulatory requirements and
expectations; see a comparison of the current guidance from leading regulatory agencies
including the FDA, EMA, TGA and key industry associations such as the Parenteral Drug
Association; see a recap of the enforcement options available to the FDA, including
imposition of the Application Integrity Policy (also known as the "Fraud Policy"); discuss
and learn from selected current real-life case histories; and hear advice for how to prevent,
detect and react to data integrity problems so as to minimize business and regulatory risk.

AGENDA
Day One (11:00 AM - 5:00 PM EDT) Day Two (11:00 AM - 5:00 PM EDT)

11.00 AM: Session Start  Welcome and time for questions from day one
 Introductions  Comparison of current data integrity guidance documents from
 Instructor regulators and industry sources
 Participants  FDA
 Determination of participant’s desires and expectations for the session  EMA

 Introduction to data integrity  PDA Code of Conduct (industry viewpoint)

 Defining data integrity  PIC/S (Pharmaceutical Inspection Convention/Pharmaceutical

 “ALCOA” acronym meaning Inspection Co-Operation Scheme)

 Criticality of data integrity to “GXP”-governed activities  Consequences of noncompliance
 “Fraud” versus innocent conduct that can lead to data integrity lapses  FDA:
 Examples from other industries (automobiles, finance, etc.)  Application Integrity Policy

 Historical Perspectives  Disqualification of Clinical Investigators

 The American “Generic Drug Scandal” of the late 1980s- early 90s and  Civil and criminal sanctions
 Case study: Consent decree imposed on a company outside the US;
its consequences
 Expansion of computer system use in GXP operations and its impact implications of extraterritorial jurisdiction asserted by FDA
 Emergence of current worldwide concern among regulators  EMA/MHRA
 Other agencies
 Motivators behind deliberate wrongful conduct
 Business consequences – Case study examples
 “Achieve gain”
 “Avoid pain”  Steps to take to prevent, detect and react to data integrity problems
 Managing to avoid the “Law of Unintended Consequences”  Fundamentals of good documentation practice
 Retention of true copies in lieu of originals – is it allowed, and if so,
 Computer system issues
what are the expectations?
 Audit trails
 Signs you may have a data integrity problem
 Changes to data
 How to react if you suspect deliberate falsification
 Metadata implications for data integrity
 Involving legal counsel and external expert assistance
 Computer System Controls required by the US and EMA
 Considerations for voluntary disclosure to regulators
 FDA Case studies of data integrity issues
(with concurrence of legal counsel)
 GMP
 GCP  Questions, general discussion, summary and wrap up
 GLP

WHO WILL BENEFIT

This course is designed for people who generate, review and archive data in support of marketing authorization applications to health regulatory agencies such as the FDA,
EMA and TGA, and those who generate, review and archive GMP, GCP and GLP data in manufacturing, clinical trials and pre-clinical testing laboratories. The following
personnel will benefit from the course:

 Senior Quality and Regulatory Affairs managers  Production personnel

 Clinical and Manufacturing Quality professionals  Laboratory Managers
 Regulatory Affairs professionals  Clinical Operations Personnel
 Compliance professionals  Drug Safety (Pharmacovigilance) Personnel
 In House Legal Counsel  R&D and Quality Control Scientists
 Production supervisors  Quality auditors
 Manufacturing personnel

www.complianceonline.com
6201 America Center Drive, Suite 240 San Jose, CA 95002 | Fax: 650-362-2367 | Email: customercare@complianceonline.com | Toll Free: +1-888-717-2436
 2-Day Virtual Seminar by Ex-FDA Director
DATA INTEGRITY: FDA/EMA/TGA REQUIREMENTS AND IMPLEMENTATION

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Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will
receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On
request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a
credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without
notice.

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www.complianceonline.com
6201 America Center Drive, Suite 240 San Jose, CA 95002 | Fax: 650-362-2367 | Email: customercare@complianceonline.com | Toll Free: +1-888-717-2436