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Current issues in assuring data integrity in life sciences : 2 Days Seminar
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Ticket Price: Seminar One Registration - $1,295.00 Special Group Discount Register for Four attendees - $ 4995
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
Agenda
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
Speaker Details
Chinmoy RoyBSEE, 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.