Two Day Workshop: Assuring Data Integrity in the Life Science Industry (Brisbane, United States - April 20-21, 2017) - Research and Markets

DUBLIN--()--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.

Areas Covered:

- 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

Agenda:

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

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Biotechnology, Pharmaceuticals, Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Biotechnology, Pharmaceuticals, Medical Devices