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Data Integrity: FDA/EU Requirements and Implementation
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There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.
This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.
This two-day course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
- Understand what data integrity is and why it is so important for public health
- Learn why there are so many data integrity issues
- Learn about the FDA/EU/PICS/MHRA/WHO requirements for data integrity
- Understand how to define and archive raw data from hybrid systems: electronic vs. paper
- Be able to specify and validate Part 11 compliant software functionality
- Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
- Understand FDA's New and ongoing Part 11 inspection and enforcement practices
- Learn how to develop and implement corrective and preventive action plans in response to inspection reports
- Learn how to avoid and/or respond to FDA inspectional observations and warning letters
- Learn how to prevent and detect data integrity issues
Who Will Benefit:
- QA managers and personnel
- Laboratory managers and supervisors
- Production managers and supervisors
- IT/IS managers and system administrators
- Software developers
- Regulatory affairs
- Training departments
- Documentation departments
Dr. Ludwig HuberChief Advisor - Global FDA compliance, Labcompliance
- Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
- Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
- Presenter of the Year of the Institute for Validation and Technology
- Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
- Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
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