Dr Bob McDowall
R.D. McDowall Ltd.
Referent:innen
Yves Samson
Kereon
For Attendees Only
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity.
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity.
Zielgruppe
- 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
The aim of this one day course is to understand what can be defined as raw data and to explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example:
- What is a “quality decision” and what is the impact of having to define raw data for the process or system?
- Can raw data be equivalent to complete information and complete data?
- Should we treat manufacturing “information” and laboratory “data” as the same?
Background
FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:
- Records include the raw data which is used to generate other records
- For electronic records regulated users should define which data are to be used as raw data
- At least, all data on which quality decisions are based should be defined as raw data
In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.
Programm
Data, Information and Knowledge
- Data vs information vs knowledge
- From knowledge to insight
- DIKI model
- Product, Prcocess, Data
Regulations
- US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete Information
- EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspective + Chapter 4 Draft 2025
Understanding GMP Definitions and Regulations for Raw Data
- Original record / record
- Raw data – MHRA GMP and US GLP definitions
- Data and metadata
- True copy
- Complete data
- Initial data
- Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems
- Raw Data for PLCs
- PLCs linked to a SCADA system
- SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
- Hybrid CDS and manual input to the LIMS
- Electronic CDS with automatic transfer to the LIMS
- Managing sample management and preparation records
Workshop: Defining Raw Data for Production, QA and Laboratory Systems
Can a True Copy be Raw Data?
Workshop : What are Raw Data for Quality Decisions
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 € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 695
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
We offer you a discount of € 600 if you book this training course together with course "Data Integrity Master Class" on 26-28 August 2026 here.
ECA Members € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 695
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
We offer you a discount of € 600 if you book this training course together with course "Data Integrity Master Class" on 26-28 August 2026 here.
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
Tue, 25 August 2026, 09.00 – 17.15 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Non ECA Member*: | € 1290,- |
| EU/GMP Inspectorates*: | € 695,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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