FDA Data Integrity: Do’s, Don’ts and Real-World Case Studies
June 19, 2018 - 01:30 PM EDT | 10:30 AM PDT | 12:30 PM CDT Duration 90 Minute
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Listen fron Chinmoy Roy BSEE, MSCS (Award winning US FDA Data integrity & CSV expert 37+ years exp)"
Mark your calendar for Tuesday, June 19 for Data Integrity training by the award winning Data Integrity expert 37+ years exp.
Data Integrity audits project a moving goal post. Issues that were top warning letter vote getters have made way for newer ones to include Cybersecurity etc. Our Data Integrity courses which are offered around the world are renowned for addressing such evolving trends. Consequently, they have attracted record attendances. Attendee feedback suggests the uniqueness of our offerings. Particularly significant is the feedback from those who attended similar courses offered by other companies.
Chinmoy Roy, our course instructor, is one of the world’s first to design, implement and obtain “fit for use” certification for the world’s largest paperless biologics manufacturing facility in the late 1990s. He is a practicing Data Integrity auditor. Former FDA inspectors include him on their 3rd party and mock audit teams. He also continues to provide consulting services in the design and implementation of Data Integrity infrastructures to major multinational companies. His lucid and pragmatic presentation style and interaction with the trainees/conference attendees, has earned him the “Speaker of the year” award from attendees of the world’s prestigious conference on Data Integrity.
The webinar will address case studies, inspection approaches and trends. This webinar is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups.
• The definition of data integrity according to regulatory bodies
• The FDA's position on Data Integrity
• Data Integrity Issues & Warning Letters
• Data Life Cycle design and controls
• Roles and responsibilities of different groups in ensuring data integrity
• What data integrity SOPs do auditors expect to see during audits
• Data Integrity in Cloud, Virtualization and Big Data
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
• Laboratory personnel
Industries who can attend
This 90-minute online course is intended for professionals from drugs and biologics to devices and diagnostics, nearly every organization with FDA-regulated products will benefit from this informative and practical webinar.
Get a Training CD for your team if you are not available on 19 June 2018 .