Boston Professional Events List


Current issues in assuring data integrity in life sciences : 2 Days Seminar


Date
Nov 14, 2017 - 08:30 PM
Organizer
wcsseminars
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

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.
 

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

    Chinmoy RoyBSEE, MSCS US FDA Expert Data integrity & CSVSubject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systemsChinmoy 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. 



Agenda


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 & CSVSubject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systemsChinmoy 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.His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc.

Event Categories
Keywords: Clinical , design , Health , HealthCare , implement, industry , Management , pharmaceutical , program , science




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