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

Dr. Ludwig Huber, Chief Advisor - Global FDA Compliance, Labcompliance
Radisson Blu Hotel Dublin Airport, Ireland
| Tuesday, October 11, 2016 | Wednesday, October 12, 2016

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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

  • 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

Who will Benefit:

  • QA managers and personnel
  • Laboratory managers and supervisors
  • Production managers and supervisors
  • Analysts
  • IT/IS managers and system administrators
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants

Companies and departments:

  • Pharmaceutical development and Quality control laboratories
  • Quality control laboratories of API manufacturers
  • Medical device companies
  • Contract laboratories
  • Clinical Research Organisation
  • Suppliers and service providers of instruments and computer systems

Course Outline:

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

Day One (8:30 AM - 4:30 PM) Day Two (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
  • Regulations and guidelines related to data integrity
  • Main reasons for non-compliance
  • Warning letter statistics by subject and countries
  • 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
  • Examples on how to implement Annex11 and Part11

Module 3

Cost effective Validation of software and computer systems

  • Selecting the right validation lifecycle model
  • Going through examples of a complete computer system validation from planning to reporting
  • Examples for risk based DQ, IQ, OQ and PQ
  • Vendor assessment and supplier agreements
  • Validation of existing systems
  • Maintaining the validated state: Revalidation vs. periodic review
  • Recommendation for network qualification and cloud Computing

Module 4

Aligning data integrity with the company’s quality system and Code of Conduct

  • Contributions to poor quality
  • Consequences of poor quality systems
  • Recommendations from the FDA
  • ICH Q10 – The quality system for pharma industry
  • Aligning key requirements with data integrity: e.g., CAPA system, training, internal, audits, risk management and ongoing improvements
  • How a Code of Conduct helps to ensure data integrity
  • Definition and contents of a related Code of Conduct

Day 2 - Lectures and Workshop Exercises

Module 5

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 6

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
  • Improving effectiveness through standardization

Module 7

Strategies to detect and avoid integrity issues

  • Recruit, train and retain employees who will be responsible for ensuring data integrity
  • Possible causes for data integrity breaches
  • Show consequences of data integrity violations
  • Understand system vulnerabilities, motivation and likelihood operators might compromise data
  • Understand high risks in the data lifecycle
  • Formally investigate internal hints about data falsification
  • Learning from internal audits and FDA inspections

Module 8

Data Integrity Auditing: Internal audits 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
  • Follow-up on CAPA through verifying effectivess

  • 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions

Meet Your Instructor

Dr. Ludwig Huber
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, 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"

For more information, visit

Register Online


Seminar One Registration (USD)

October 11-12, 2016, Dublin, Ireland


Seminar One Registration (With 2 Nights Stay)

October 11-12, 2016, Dublin, Ireland

You Save: $2,695.00 (22%)*

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October 11-12, 2016, Dublin, Ireland
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Your registration fee includes the workshop, all course materials and lunch.

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How to Reach

General Driving Directions:

Driving Directions from Dublin Airport:
  • Head south-west - 4 m
  • Continue straight - 450 m
  • Turn left onto R132 - 600 m
  • At the roundabout, take the 1st exit - 400 m
  • Slight left - 73 m
  • Turn left - 54 m
  • Turn left. Destination will be on the right

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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Local Attractions

Kilmainham Gaol is a former prison in Kilmainham, Dublin, Ireland. It is now a museum run by the Office of Public Works. Many Irish revolutionaries, including the leaders of the 1916 Easter Rising, were imprisoned and executed in the prison by the British. Kilmainham Gaol was decommissioned as a prison by the Irish Free State government in 1924. Later, final restorations of the site were completed in 1971 when Kilmainham Gaol chapel was re-opened to the public having been reroofed and refloored and with its altar reconstructed. It now houses a museum on the history of Irish nationalism and offers guided tours of the building. An art gallery on the top floor exhibits paintings, sculptures and jewelry of prisoners incarcerated in prisons all over contemporary Ireland. Kilmainham Gaol is one of the biggest unoccupied prisons in Europe. Now empty of prisoners, it is filled with history. It has aptly been described as the 'Irish Bastille'.

Phoenix Park is an urban park in Dublin, lying 2–4 km west of the city centre, north of the River Liffey. Its 11 km perimeter wall encloses 1,750 acres, one of the largest walled city parks in Europe. It includes large areas of grassland and tree-lined avenues. There are 351 identified plant species in the park; three of these are rare and protected. The park has retained almost all of its old grasslands and woodlands and also has rare examples of wetlands. Deer were introduced into the park in the 1660s; the current 400–450 fallow deer descend from the original herd. The park also contains several sports grounds for football, hurling, soccer, cricket and polo.

The National Museum of Ireland is the national museum in Ireland. It has three branches in Dublin and one in County Mayo, with a strong emphasis on Irish art, culture and natural history. The National Museum of Ireland – Archaeology on Kildare Street has displays on prehistoric Ireland, including early work in gold, church treasures and objects from the Viking and medieval periods. The Kingship and Sacrifice exhibition includes well preserved bog bodies and Ralaghan Man. There are special displays of items from Egypt, Cyprus and the Roman world, and special exhibitions are regularly mounted.

Saint Patrick's Cathedral in Dublin, also known as The National Cathedral and Collegiate Church of Saint Patrick, Dublin, was founded in 1191. It is the largest church in Ireland and one of Dublin's two Church of Ireland cathedrals. It has a 43-metre spire. Christ Church, the other cathedral, is the diocesan cathedral of the diocese of Dublin and Glendalough. The cathedral has over 300,000 visitors a year. Throughout its long history the cathedral has contributed much to Irish life, and one key aspect of this relates to the writer and satirist Jonathan Swift, author of Gulliver's Travels, who was Dean of the cathedral from 1713 to 1745. Many of his famous sermons and "Irish tracts" (such as the Drapier's Letters) were given during his stay as Dean. His grave and epitaph can be seen in the cathedral, along with those of his friend Stella.

The Chester Beatty Library was established in Dublin in 1950, to house the collections of mining magnate, Sir Alfred Chester Beatty. The present library, on the grounds of Dublin Castle, opened on February 7, 2000, the 125th anniversary of Beatty's birth and was named European Museum of the Year in 2002. The library's collections are displayed in two collections: "Sacred Traditions" and "Artistic Traditions". Both displays exhibit manuscripts, miniature paintings, prints, drawings, rare books and some decorative arts from the Islamic, East Asian and Western collections. The library is one of the premier sources for scholarship in both the Old and New Testaments and is home to one of the most significant collections of Islamic and Far Eastern artefacts. The museum also offers numerous temporary exhibitions, many of which include works of art on loan from foreign institutions and collections. The museum contains a number of priceless objects, including one of the surviving volumes of the first illustrated Life of the Prophet and the Gospel of Mani believed to be the last remaining artefact from Manichaeism.

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