Data Integrity Master Class - Online Training Recording

Course No. 21318



Dr. Bob McDowall

Dr. Bob McDowall

R.D. McDowall Ltd.

Yves Samson

Yves Samson


Dr. Wolfgang Schumacher

Dr. Wolfgang Schumacher

ehemals/formerly F. Hoffmann-La Roche

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken


  • Your will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
  • You will get a deeper understanding what FDA and European inspectors expects from pharmaceutical companies in regard to Data Integrity
  • You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
  • You will learn how to prepare your company for a successful inspection in regard to Data Integrity
  • You will understand how to establish an effective Data Governance System
  • You will learn how to investigate Data Integrity issues in your company


Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue be the focus of many GMP inspections.

As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe  the regulatory expectations of  Data Integrity.

Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business.

Target Group

The online training is directed at
  •  Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
  •  Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
  •  Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.


Regulatory Update
  • EU GMP Requirements
    • Chapter 4, Annex 11
  • Guidance Documents Overview (state of the art)
  • “These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is this correct?
    • Data Governance, Dynamic Data
Quality Culture for Data Integrity
  • Regulatory expectations for a data integrity quality culture
  • Role senior management in creating the culture
  • Components of a quality culture
  • Reinforcement of the culture
Data Flow Analysis
  • Objective and purpose
  • Electronic data flow
  • Complete data flow
  • Identification of possible weaknesses
Case Study/Workshop on Data Flow Analysis

Metrics for Data Integrity
  • Metrics in the context of a corporate data integrity programme
  • Suggested metrics in the assessment phase
  • Suggested metrics in the operational phase
QA Oversight for Data Integrity
  • Data integrity training
  • Enforce data flows
  • Reviews
  • Internal inspection
  • Audit of external organisations
Case Study/Workshop on QA Oversight for Data Integrity

Control of Master Templates and Blank Forms
  • Why is control of master templates and blank forms important?
  • Regulatory requirements from FDA, MHRA, WHO, EMA and PIC/S
  • Devising and controlling the master template
  • Operational use of the blank forms
  • Do you really want to work this way?
Data Integrity in the Pharmaceutical Quality System / Data Governance
  • Which PQS elements need to be added or updated?
  • The Data Integrity Program
    • Priorities (immediate/short/mid-term)
    • Capacity, Timing
  • Governance responsibilities
  • Data governance vs. IT governance
  • Elements of a data governance
  • Embedding data governance into the PQS
Audit Trail Review
  • Regulatory Overview
  • Essential Audit Trails in QA/QC/Manufacturing
  • Risk-based Approach
  • What about legacy systems w/o Audit Trail?
  • Who shall review Audit Trails? Documentation
  • What process and documentation is appropriate in case of deviations/discrepancies?
Second Person Review
  • Regulatory and guidance document requirements for the second person review
  • Role of the second person Review
  • Scope of the second person Review
  • Documenting the review for paper, hybrid and electronic systems
  • Facilitated discussion on Second Person review
Facilitated Discussion on Second Person Review

Preparing your Company for an Data Integrity Inspection
  • How to present the DI status and future approach?
  • Gap analysis
  • Training program coverage
  • Experience from FDA inspections – Hot Buttons
DI Inspections
  • Basis for Inspections: “PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments”
  • Data Integrity Assessment during Inspection
    • Quality Control, Manufacturing
  • Inspection Findings
Case Study/Workshop: Data Inspection Findings

Vulnerability of Records
  • What is record vulnerability?
  • Protection and security of electronic records requirements
  • What can go wrong? Scope of misfortunes that can impact records
  • Assessment of record vulnerability and implementation of control measures
Case Study/Workshop on Vulnerability of Records

Case Study Data Migration: Preserving Content and  Meaning
  • Principles of data migration
  • Design of the migration process
  • Risk-based elaboration of the verification strategy – case study examples
Cybersecurity / Cloud Computing / Time Synchronisation
  • Cybersecurity securing data integrity
  • Robust IT infrastructure
  • Time Synchronisation
  • Qualification of time dissemination
Results of a Data integrity Audit from a Contract Laboratory
  • Audit context, Audit scope, Findings, Root causes
Data Integrity Investigations
  • What are data integrity investigations?
  • Human and technical triggers for DI investigations
  • Who should investigate the problem?
  • Process description and how to document a DI Investigation
  • Should we inform regulatory authorities?
Case Study/Workshop on Data Integrity Investigations

Options for Long Term Data Retention
  • Proprietary v open standards for laboratory data
  • Options for long term retention:
    • Keep original system, Virtualisation, Data migration
Case Study/Workshop: Justifying Long Term Solutions
Recording from 30 August 2023
Duration of the recording: approx. 15 h 38 min


This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more

ECA-Member*: € 2090,-
Regular Fee*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Not available
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
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“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023