Thursday, April 19, 2018, 6:00 PM – 9:30 PM PST
Oyster Point Yacht Club, 911 Marina Boulevard, South San Francisco, CA 94080
Biopharmaceutical industry regulators have a renewed focus on Data Integrity (DI). In spite of company managements’ unflinching commitment to resolving data integrity issues, they continue to be cited with warning letters and 483s. This may be attributed to their oversimplification of the issue by making it an intensive documentation exercise and solely focusing on system-based assessments. Furthermore, employees erroneously view DI procedures as unique to their business unit or department or group thereby rendering procedures developed by one business unit as being not applicable to other units. Instead, they need to adopt the “least burdensome approach” where DI procedures are established using a process centric view instead of a system centric one.
The “least burdensome approach” involves the smallest investment of time, effort and resources. Common core activities that affect data integrity across all groups and divisions are identified and control measures are established to address these vulnerabilities. Such an approach helps to ensure the establishment of a data integrity program that is relevant across the enterprise.
Applying the “least burdensome approach” is the focus of this presentation. It will provide answers to the following:
Why is process oriented the right approach to establish a data integrity assurance program;
Using process oriented approach to conduct a Data Integrity Risk Assessment;
What is DI’s 5P model and how to use it to establish a DI Assurance program;
What DI documents regulators expect to see and what should these documents contain;
Review of DI related 483s and Warning Letters for the past 5 years and current citation trend;
Advanced topics: Data Integrity Maturity model.
Chinmoy Roy is a world recognized expert in Data Integrity, Computerized Systems Validation, Risk Assessment and Manufacturing IT and automation systems. An engineer and computer scientist, he is one of the early implementers of a fully integrated paperless manufacturing IT system at one of the world’s largest biologics manufacturing facility located in California. He has also consulted with multinational companies worldwide to assist them in successfully establishing their Data Integrity plans. He is also an auditor and regularly conducts joint audits with former FDA inspectors. His implementation background provides him the expertise to establish data integrity programs that spans all vertical layers of management and across all horizontal layers of the enterprise.
6:00 PM Registration/Networking*
7:00 PM Complementary Dinner (buffet)
7:45 PM Announcements
8:00 PM Presentation/Q&A
9:30 PM Closing
*No host bar
Early birds: $45 / $50 (member / nonmember)
Regular: $60 / $70
Last minute: $90 / $100
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