Assuring Data Integrity in the Life Science industry

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.