$895 – $3,495

2 Day Seminar Assuring Data Integrity in the Life Science industry

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Location 1: Boston (Hilton Garden Inn Boston Logan Airport)

Apr 06 – 07 ,2017, MA 02128

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2 Day Seminar Assuring Data Integrity in the Life Science industry

12 RAPS CREDITS

Location 1: Apr 06 – 07 Boston

Location1 Hilton Garden Inn Boston Logan Airport

Address: 100 Boardman St, Boston, MA 02128, USA Phone: +1 617-567-6789

Location 2: Apr 20 – 21 San Francisco, CA

Location2 Homewood Suites by Hilton San Francisco?

Address: 2000 Shoreline Court, Brisbane, CA 94005, United States ,Phone: +1 650-589-1600

Call our customer care to get the Hotel details Toll Free 844-267-7299

An Interative Workshop Presented BY WCS & Chinmoy Roy BSEE MSCS
Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

Each attendee will receive 2-Day workshop materials, Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS

Data integrity continues to be one of the topmost concerns of regulators worldwide. With regulatory agencies actively hiring computer savvy personnel, we can only expect increased and rigorous audits of data integrity.

After successful workshops last year that filled to capacity, WCS is again teaming up with Chinmoy Roy to provide this all new 2-day workshop. It focuses on emerging data integrity concepts and audit focus areas. Attending this workshop will enable attendees to not only become familiar with data integrity fundamentals and practices but to also effortlessly identify and remediate potential data integrity issues before auditors do.

Addressed will be case studies, inspection approaches, 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

Meet Your Instructor:

Chinmoy Roy BSEE MSCS

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 35+ years of experience. He is an internationally recognized subject matter expert 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.
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. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing

Please call for any Assistance of our customer support on 844-267-7299

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Location 1: Boston (Hilton Garden Inn Boston Logan Airport)

Apr 06 – 07 ,2017, MA 02128

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