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Data Integrity: FDA/EU Requirements and Implementation  

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Seminar Summary:

There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations. (see full course description)

 

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Training Course Syllabus:


Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop by Dr. Huber

Course Description:

There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483´s and Warning Letters quote data integrity as deviations from GxP regulations.

This new 2-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.

The 2-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.


Learning Objectives:
Attendees will:

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

Additional Bonus Material for easy implementation
(all available as Web download )

43-page primer “Electronic records, electronic signatures” (authored by Dr. Ludwig Huber)
10 SOPs related to data integrity, data security and validation of computer systems and data
Checklists related to Annex 11, Part 11 and data integrity

Course Outline:
Sessions indicated with (*) include one or more workshop exercises

Day One (8:30 AM - 4:30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

Day 1 – Lectures and Workshop Exercises

Module 1

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
Module 2

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
Module 3

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
Module 4

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 Two (8:30 AM - 4.30 PM)

Day 2 - Lectures and Workshop Exercises

Module 5

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
Module 6

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
Module 7

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
Examples
Module 8

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

Seminar Summary:

There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations. (see full course description)

print this agenda print agenda for the Data Integrity: FDA/EU Requirements and Implementation training seminar

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