Seminar Information


Data Integrity: FDA/EMA Requirements and Implementation


Seminar Title
Data Integrity: FDA/EMA Requirements and Implementation
Event Type
Seminar
Seminar Date
14-07-2021 to 15-07-2021
Last Date for Applying
04-07-2021
Location
San Jose, California, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
complianceonline
Organizing/Related Departments
Sales & marketing
Organization Type
Event Organizing Company
Seminar Category
Both (Technical & Non Technical)
Seminar Level
All (State/Province/Region, National & International)
Related Industries

Computer/Technology

Automobile

Manufacturing

Medical/Healthcare/Hospital

Location
San Jose, California, United States

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).

The use of computer systems in virtually every aspect of data acquisition, storage, and analysis can help preserve data integrity and reduce or eliminate many errors, but the same technology can also create unique problems that must be prevented and managed.

In this two day workshop conference you will learn the meaning of "data integrity"; be exposed to some of the history that influences current regulatory requirements and expectations; see a comparison of the current guidance from leading regulatory agencies including the FDA, EMA, TGA and key industry associations such as the Parenteral Drug Association; see a recap of the enforcement options available to the FDA, including imposition of the Application Integrity Policy (also known as the "Fraud Policy"); discuss and learn from selected current real-life case histories; and hear advice for how to prevent, detect and react to data integrity problems so as to minimize business and regulatory risk.

Registration Fees
Not Mention
Registration Ways
Email
Website
Address/Venue
Virtual Seminar, 6201 America Center Drive Suite 240 San Jose, CA 95002, USA 
Contact
Ashutos Swain

[email protected]

     +1-888-717-2436