Hilton Garden Inn San Diego / Del Mar 11025 Vista Sorrento Parkway | San Diego, CA | 92130 ,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone: 347 282-5400

Course “2020 Current issues in assuring data integrity in life sciences “ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
 

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.

This training focuses on implementing Data Integrity programs using “the least burdensome” approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investigations among many others.

Addressed will be case studies, inspection approaches, and trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements.  These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies 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 

Course Outline:

DAY ONE (08:30 AM to 05:00 PM)

 

Module 1

Data and Data Integrity: concepts, meaning of integrity, data dimensions

   • Practically speaking, what is data, raw data, metadata

   • Meaning and principles of DI

   • Data types and their relevance to DI

   • DI dimensions with examples of 483 and Warning letters

   • Why is DI not considered to be a new requirement

 

Module 2

Primer on 21 CFR Part 11

   • 21 CFR Part 11 (P11) and Annex 11 (A11) fundamental concepts

   • P11 Scope and Application guide

   • Why is Data integrity not the same as x11 (P11 and A11)

 

Breakout group exercise: Mapping DI to Part 11

 

Module 3

Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS 

   • What are similarities and differences between the guidance

 

Module 4: 

"Implementing a DI assurance plan using the “Least burdensome approac”

   • PQLI and its relevance to Data Integrity

   • What is the “Least Burdensome Approach”

   • Why DI issues occur and how to avoid them proactively

   • DI implementation plan: the 5p model and the Controls Triad

   • What DI SOPs do auditors want to see and what should their contents be

 

 

DAY TWO (08:30 AM to 04:30 PM)

 

Module 5:

Data Integrity in IT and Manufacturing IT systems

    • Data Integrity impact due to the architecture of IT system

    • Implementing Active Directory service, Group policy etc. to attain DI

    • DI susceptibilities of hybrid systems commonly found in manufacturing IT systems  

   • DI risks when generating electronic records which are true copies of paper records

   • What data integrity items to review for during a Electronic Batch review

 

Module 6

Data Integrity in the Laboratory

    • Why is laboratory Data Integrity the key focus of all regulatory audits

    • Laboratory Data Integrity audit trend and what is needed to avoid citations

   • Conducting DI risk assessment, trainee participation required 

   • Core documentation that you must have to demonstrate laboratory Data Integrity

   • What should be the contents of the documents

   • What is the role of the laboratory manager in fulfilling DI

 

Breakout group exercise: Develop an Audit Trail review SOP

 

Module 7

Data Integrity considerations in Clinical Trial Systems (CTS)

     • Mobile computing issues

     • Latest US FDA’s Part 11 guidance for CTS

     • US FDA’s latest Cybersecurity guidance for CTS

 

Module 8

How is Data Integrity audited

    • Developing a Data Integrity audit checklist

    • Critical thinking skills for Internal Auditors

    • How can you effectively use your Data Integrity Maturity Model during audits

   • FDA’s new approaches to data integrity audits