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Data Integrity: FDA/EMA/TGA Requirements and Implementation
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.
Upon completing this course participants should:
- Understand the meaning of the term “data integrity” and the importance of the acronym “A.L.C.O.A.” to regulatory agencies
- Understand the difference between innocent lapses and deliberate wrongful conduct
- Be aware of some of the key historical events that form the basis for regulators’ concerns about data integrity
- Understand some of the common motivations for deliberate wrongful conduct that results in data falsification
- Understand the impact of the use of computer systems on the maintenance of data integrity, and what types of system controls are mandated by various agencies around the world
- Be aware of the possible business and regulatory consequences of noncompliance
- Understand the important steps to take to prevent, detect and react to data integrity problems
Who will Benefit:
This course is designed for people who generate, review and archive data in support of marketing authorization applications to health regulatory agencies such as the FDA, EMA and TGA, and those who generate, review and archive GMP, GCP and GLP data in manufacturing, clinical trials and pre-clinical testing laboratories. The following personnel will benefit from the course:
- Senior Quality and Regulatory Affairs managers
- Clinical and Manufacturing Quality professionals
- Regulatory Affairs professionals
- Compliance professionals
- In House Legal Counsel
- Production supervisors
- Manufacturing personnel
- Production personnel
- Laboratory Managers
- Clinical Operations Personnel
- Drug Safety (Pharmacovigilance) Personnel
- R&D and Quality Control Scientists
- Quality auditors
Use coupon code NB5SQH8N and get 10% off on registration.
Contact the event managers listed below for more information about how you can participate at the Data Integrity: FDA/EMA/TGA Requirements and Implementation.
Clinical and Manufacturing Quality professionals
Regulatory Affairs professionals
In House Legal Counsel
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