Breakdown What FDA Requires in Assuring Data Integrity in the Life Science Industry
Addressed will be development of a Data Integrity Policy, contents of Data Governance directives documents such as Code of Conduct, Roles and Responsibilities etc.
BOSTON, May 30, 2019 /PRNewswire-PRWeb/ -- World Compliance Seminars today announced a live seminar on Current regulatory thinking on Data Integrity on July 08-09, 2019 in Boston, MA. This peer recommended interactive workshop is always selected by professionals at global healthcare, pharmaceutical, biotech and medical device organizations.
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.
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.
WCS addresses "how to" of data integrity and not the "what is" data integrity.
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SOURCE World Compliance Seminars
