Overcoming data integrity challenges in life sciences

Overcoming Data Integrity challenges in Life Sciences

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

http://www.onlinecompliancepanel.com/

Instructor Profile:

Chinmoy Roy has 40+ years of experience in the US Life sciences industry. He is an internationally recognized Subject Matter Expert (SME) in Data Integrity, CSV, CFR 21 Part 11, Annex 11 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. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training.

He was one of the early implementers of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and Validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech, was a precursor to FDA's issuance of Part 11's Scope and Application guidance in 2003.



Description:

This interactive two-day workshop provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world, this workshop provides participants with the knowledge, approaches and techniques to effectively establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for novices as well as experienced personnel from QA, IT, manufacturing, laboratory, regulatory and validation groups. It should also be of special interest to mid-level as well as senior level management.

Addressed will be data integrity case studies, inspection approaches and 483s and warning letters. Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc.



Objectives of the Presentation:

What are the recent regulatory changes for Data IntegrityWhat should be the management structure for DI accountabilityWhat are the documentation requirements for Data integrityWhat factors to consider before establishing a DI planHow does CFR 21 Part 11 and Annex 11 requirements translate to data integrity requirementsWhat are the success factors for a DI programHow is DI validatedHow is DI audited.



Areas Covered:

What is Data integrityData Life Cycle design and controlsAttributes of Data Integrity and how they map to predicate rulesHow do you know you have a Data Integrity problem in your companyElements of a Data Integrity Assurance programRoles and responsibilities of different groups in ensuring data integrityWhat data integrity SOPs do auditors expect to see during audits and should their contents beValidating Data Integrity.



Who can Benefit:Pharmaceutical industry / Medical device industry / Healthcare industry personnelDevelopers of software for use in Life Sciences industryValidation service providers, IT service providersManufacturing personnel, Manufacturing Automation system vendors and system integratorsRegulatory Affairs group, Quality UnitLaboratory personnelUsers of CloudClinical Trial Sponsors.

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Data Integrity challenges in Life Sciences


http://www.onlinecompliancepanel.com/workshop/Overcoming-Data-Integrity-challenges-in-Life-Sciences-800017/NOVEMBER-2016-DS-SLIDESHARE


Overcoming data integrity challenges in life sciences

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