DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Assuring Data Integrity in the Life Science Industry" conference to their offering.
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, we are 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.
- 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
Some Advanced Data Integrity Topics Include:
- Data Integrity triad
- Data Integrity Maturity Model
- Developing critical thinking skills
- Data Integrity Audit trends
Day One (08:30 AM to 05:00 PM)
Module 1 Data Integrity: concepts, requirements, definitions, approaches
Module 2 Why Data integrity issues occur
Group exercise: DI Directives & SOPs
Module 3 Implement enterprise DI program
Module 4 In the trenches - implementing DI.
Day Two (08:30 AM to 04:30 PM)
Module 5 Data Integrity in the Laboratory
Module 6 DI in Manufacturing IT & Clinical trial systems
Module 7 Advanced topics
Module 8 Update on current DI audit and enforcement trends using most recently issued 483's and Warning letters
For more information about this conference visit http://www.researchandmarkets.com/research/mfk6th/assuring_data