Course "Data Integrity: FDA/EU Requirements and Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
Day 1 Schedule
Lectures and Workshop Exercises
Definitions, requirements and approaches for data integrity
- Definition of data integrity: ALCOA+
- The importance of data integrity for public health
- Main reasons for non-compliance
- Regulations and guidelines
- FDA's inspection and enforcement strategy of Part 11
- Lessons from recent FDA Warning Letters and how to avoid them
Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
- Objective, scope, current situation and future of Part11
- Requirements for electronic records
- Requirements for electronic and digital signatures
- Additional requirements from the PICS/EU Annex 11,
- Developing a gap analysis
- Upgrading existing or purchasing new systems:
- Six steps for implementation of Part11/Annex 11
Strategies to detect and avoid integrity issues
- Recruit, train and retain employees who will be responsible for ensuring data integrity
- Preventing data integrity issues: Going through details of ALCOA+
- Possible causes for data integrity breaches
- Understand system vulnerabilities, motivation and likelihood operators might compromise data
- Understand the company's quality culture
- Understand high risks in the data lifecycle
- Learning from internal audits and FDA inspections
The Quality System as Prerequisite for Data Integrity
- Contributing factors to poor quality
- Consequences of poor quality systems
- Recommendations from the FDA
- Developing a Quality Culture
- ICH Q10 - The quality system for pharma industry
- Implementing key requirements: e.g., CAPA system, failure investigations, training, audits
- Assessment of data integrity risks
- Steps for on-going improvement
Day 2 Schedule
Lectures and Workshop Exercises
Cost effective Validation of software and computer systems
- Selecting the right validation lifecycle model
- Going through examples of a complete computer system validation from beginning to end
- How risk assessments can help to determine the type and extent of validation
- Defining user requirements based on risk
- Vendor assessment and supplier agreements
- Testing and documenting installation
- Going through examples for OQ and PQ testing
- Maintaining the validated state
Definition and Handling of Raw Data
- Definition of Raw Data
- Examples of raw data
- Raw data for paper based and electronic systems
- Criteria for electronic raw data with paper print-outs
- Raw data management along the data lifecycle
- Changing of raw data
- Archiving of raw data from electronic and hybrid systems
- Going through examples
Good documentation practices to ensure data integrity
- Requirements for documentation ( ALCOA+)
- Documents that must be readily available
- Examples for good and bad documentation
- Good practices for paper and electronic data
- How to avoid common documentation mistakes
- The importance of global documentation
Data Integrity Auditing: Internal and FDA inspections
- Going through a typical FDA inspection as a model for internal audit
- FDA's new approaches to data integrity inspections
- Typical audit questions
- Identifying systems that must be audited based on risk
- Typical audit findings
- The importance of the exit meeting
- Writing a corrective and preventive action plan to fix data integrity audit findings
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Chief 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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