Online Seminar 2019 - 2 Days seminar Assuring Data Integrity in the Life Science industry

Overview
Due to increased regulatory focus on data integrity, biopharmaceutical companies are making a beeline to attend mushrooming training workshops and seminars on data integrity. These companies are also inviting third party auditors to their facilities to audit for data integrity. Several technical publications are devoting significant space in their journals to highlight the problem of data integrity. Glaringly absent from all these are specifics of a holistic approach to a solution for these data integrity problems.
Our clients approached us with a request to design a data integrity training program that address the “how to” of data integrity and not the “what” like existing programs do. Consequently, we set out to offer a solution-based training program instead of audit-based program offerings that is prevalent in the industry.
Our trainer, award-winning FDA data integrity compliance expert Chinmoy Roy, was a principal design architect of the world’s largest biologics manufacturing facility. This paperless manufacturing facility still continues to be the world’s “gold standard” for data integrity, complete with a web of data integrity policies, directives and SOPs. He is bringing his expertise to this workshop to address the specifics of a data integrity management infrastructure.
The training will kick off with a compendial treatment of Data Integrity fundamentals. After laying the groundwork, the workshop will transition to a format to include interactive group discussions and lectures. These will be directed towards developing and establishing an acceptable and effective Data Integrity infrastructure. Addressed will be development of a Data Integrity Policy, contents of Data Governance directives documents such as Code of Conduct, Roles and Responsibilities etc. Also addressed will be specifics of SOPs related to Data Management such as Audit Trail review SOP, Data Backup, Archive and Restore, Business Continuity, Disaster Recovery etc. Besides the specifics of Data Integrity SOPs and directives, attending the workshop will also provide answers to questions such as:
What Data integrity really means
How to navigate the maze of Data Integrity Guidances
How to conduct a Data Integrity Risk Assessment
Data Integrity challenges in use of Cloud services
And much, much more…
Chinmoy Roy is one of the world’s first to direct a team of engineers, IT, and QA teams in the design, implementation and obtaining “fit for use” certification for the world’s largest paperless biologics manufacturing facility. 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 presentations on Data Integrity at worldwide conferences earned him the prestigious award of “Speaker of the Year” by conference attendees at a leading US conference.
Plan on attending the training and also take the opportunity to network and participate in interactive discussions with fellow attendees from the biopharmaceutical companies
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
Course outline:
Day One (8:30 AM – 4:30 PM)
Module 1
Data and Data Integrity: concepts, meaning of integrity, data dimensions
•Practically speaking, what is data, raw data, metadata
•What are the principles of Data Integrity
•Data Integrity attributes with examples
•Different data types: aberrant data, orphan data, incomplete data etc.
Module 2
Primer on 21 CFR Part 11 and Annex 11
•21 CFR Part 11 (P11) and Annex 11 (A11) fundamental concepts
•P11 Scope and Application guide
•Why is Data integrity not the same as x11 (P11 and A11)
•Discuss USFDA Data Integrity Guidance of December 2018
Module 3
Data Governance
•Data Integrity Governance documents and their contents
•Data Integrity impacts due to organizational and individual behavior
•How to overcome human factors challenges to ensuring Data Integrity
•Major differences in USFDA’s DI initial and final guidance; their changing thinking
Module 4
Data Management
•Data Integrity Maturity Model
•Data Life Cycle
•Audit Trail review
•Data Backup and Restore
•Validation of Computerized Systems
Day Two (8:30 AM – 4:30 PM)
Module 5
Data Integrity in IT, Manufacturing, Laboratory systems
• How IT system architecture impacts Data Integrity
• IT configurations of Active Directory, Group policy etc. to attain Data Integrity
• DI risk assessment and how is it different from regular FMEA risk assessments
Module 6
Overcoming Data Integrity challenges with Cloud services
• Cloud types and cloud service models
• Data Integrity issues with different types and service models
• How do you validate Data Integrity issues for cloud use
• What SOPs are required to demonstrate how your company is addressing those issues
• Addressing Cybersecurity in the Cloud
Module 7
Data Integrity auditing techniques for Internal Audits
• Developing a Data Integrity audit checklist
• Critical thinking skills for Internal Auditors
• How can you effectively use your Data Integrity Maturity Model during audits
• FDA’s new approaches to data integrity audits
Module 8
Data Integrity Case Studies
• Implementing Data Integrity compliance for existing manufacturing line and laboratory
• Real World case studies – an interactive discussion
Speaker
Chinmoy Roy, BSEE, MSCS, is a seasoned Life Sciences professional with over 35 years of experience which includes the design, delivery, validation and obtaining "fit for use" certification of industry compliant Manufacturing Process Automation and IT systems for the pharmaceutical and biotechnology industry.
In late 1990s, he and his team did pioneering work with implementing a CFR 21 Part 11 compliant Manufacturing Control System and a bespoke EBR system. During "fit for use" certification, he demonstrated to the authorities the implementation challenges of Part 11’s Final Guidance of 1997. His team’s implementation efforts were a precursor to FDA’s Part 11 Scope and Application Guidance document in 2003. He also has a very broad experience in facilitating QRM sessions for large companies and has provided them with consultant oversight to establish their Quality Risk Management plans.
His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to successfully lead regulatory efforts in their respective organizations