Dr Bob McDowall
R.D. McDowall Ltd.
Referent:innen
Yves Samson
Kereon
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult
Dr Franz Schönfeld
GMP Inspector
For Attendees Only
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide” - Version 3
Zielgruppe
The courses are 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".
Zielsetzung
- 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
Background
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.
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.
Programm
Regulatory Update
- EU GMP Requirements
- Chapter 4 + Chapter 4 Draft 2025
- Annex 11 + Annex 11 Draft 2025
- 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
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
Workshop on QA Oversight for Data Integrity
Data Integrity in the Pharmaceutical Quality System / Data Governance
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 a Data Integrity Inspection
Preparing your Company for a 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
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
Workshop on Vulnerability of Records
Cloud Computing
- Cloud and GxP regulatory expectations
- Management models for cloud services
- Business continuity & resilience
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?
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
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?
Time Synchronisation
- Why is Time Synchronisation important?
- Qualification of time dissemination
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
Workshop: Justifying Long Term Solutions
Case Study: Planning Long Term Data Retention
Case Study: Planning Long Term Data Retention
- Document life cycle
- Compliant handling of transient data
- E-archiving
Key Learning Points and Final Discussion
Weitere Informationen
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language
The official conference language will be English.
The official conference language will be English.
Fees (per delegate, plus VAT)
ECA Members € 2,290
APIC Members € 2,390
Non-ECA Members € 2,490
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event including dinner on the first day, lunch on each day and all refreshments. VAT is reclaimable.
We offer you a discount of € 600 if you book this training course together with the pre-course session "Raw Data - Understanding, Defining and Managing" on 25 August 2026 here.
ECA Members € 2,290
APIC Members € 2,390
Non-ECA Members € 2,490
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event including dinner on the first day, lunch on each day and all refreshments. VAT is reclaimable.
We offer you a discount of € 600 if you book this training course together with the pre-course session "Raw Data - Understanding, Defining and Managing" on 25 August 2026 here.
Social Event
On 26 August, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
On 26 August, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
Contact
Questions regarding content:
Dr Andreas Mangel, +49 (0) 62 21 84 44 41, mangel@concept-heidelberg.de.
Questions regarding content:
Dr Andreas Mangel, +49 (0) 62 21 84 44 41, mangel@concept-heidelberg.de.
Questions regarding Organisation:
Mr Rouwen Schopka, +49 (0) 62 21 84 44 13, schopka@concept-heidelberg.de
Mr Rouwen Schopka, +49 (0) 62 21 84 44 13, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 26 August 2026, 09.00 – 17.30 h
Thu, 27 August 2026, 08.30 – 17.30 h
Fri, 28 August 2026, 08.30 – 15.30 h
Thu, 27 August 2026, 08.30 – 17.30 h
Fri, 28 August 2026, 08.30 – 15.30 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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