GMP Certification Programme

Certified Data Integrity Manager

Speakers

Data Integrity and Good

Bob McDowall
McDowall Ltd.
Documentation Practice
GMP-compliant instructions and records
18 – 20 June 2024 | Vienna, Austria

Stephan Dresen
Daiichi Sankyo Europe

Highlights
ƒ Principles of Good Documentation Practice and Data Integrity
ƒ Instructions, blank forms and records – Life cycle and Data Integrity
considerations
ƒ Good Documentation Practices for linked paper and electronic records
ƒ Life cycle of documents and Data Integrity issues
ƒ How to perform Second Person Review of Batch Records in different
formats
ƒ How to train staff in Good Documentation Practice and Data Integrity
ƒ Management and control of multilingual documents
ƒ Typical documentation failures and how to avoid them

All participants get free access to the current

version of the ECA „GMP, GCP and GDP Data
Governance and Data Integrity“ Guidancee.
Programme

Objective Programme
During this Course you will get to know the principles of Good Data Integrity Principles
Documentation Practices in the light of Data Integrity require-
ments. ƒ Basements of Data Integrity
ƒ Guidelines
You will learn ƒ Implementation of Data Integrity standards at a site
ƒ How to control blank forms and templates (Praxis example)
ƒ How to maintain Data Integrity for physical, hybrid and ƒ CARs Model (Critical Application Risks) – an implementa-
electronic records tion model based on Quality Risk Management
ƒ How to establish a compliant and pragmatic change
control process Current Inspection Observations and their Potential
ƒ How poor documentation practices and falsification can Resolution
be detected
ƒ How to train staff in Good Documentation Practice and ƒ Examples from current inspections
Data Integrity ƒ Potential CAPAs on observations
ƒ How multilingual documents can be managed and ƒ Watch-Outs and defense packages
controlled ƒ Inspectors expectations from different authorities: FDA,
ƒ How to avoid typical documentation failures ANVISA, MHRA, German MoH …

Experts will show what you need to consider to maintain GMP- Why is Control of Blank Forms Important?
compliant documentation systems throughout their life cycle.
ƒ Instructions and blank forms – Life cycle and Data
Integrity considerations
Background ƒ FDA requirements for control
ƒ Process for creation of master templates
Despite numerous regulatory guidelines poor documentation ƒ Process for operational use of blank forms
practice has become more and more a global problem and in ƒ Reconciliation mechanisms
most cases it leads to severe violations of Data Integrity princi-
ples. The citations regarding Data Integrity issues in FDA warn- Facilitated Discussion:
ing letters have been increasing dramatically over the past 3 Control of Templates and Blank Forms
years and also European Regulatory Agencies are concerned
about Data Integrity failures in poor documentation not only in
companies located in far East but also within Europe. Records and Life Cycle and Data Integrity Issues

Both FDA and UK’s MHRA have reacted to this situation by issu- ƒ Record and data lifecycle
ing guidances containing clear provisions regarding Data Integ- ƒ Understanding complete data / information and raw data
rity and documentation e.g. FDA’s CPG objective 3 which covers ƒ Controls for paper and electronic records
the laboratory Data Integrity audit or MHRA’s Guidance for In- ƒ Scanning and destroying paper records
dustry on Data Integrity. Also WHO has published a guidance
which provides provisions for data governance and contains ex- Electronic Document Management and Change
pectations for records in both paper and electronic forms. Control Systems to Ensure Data Integrity

ƒ Data Integrity expectations on an Electronic Document

Target Audience Management System (EDMS) and Change Control System
ƒ Audit Trail Review / Log File Review
This Education Course is designed for managers and staff from ƒ Fundaments of a modern EDMS
Manufacturing, QC/QA and Analytical Development Laborato- ƒ Traceability
ries of pharmaceutical companies and API manufacturers. Labo- ƒ Mapping ALCOA principles on EDMS and Change Control
ratory and QA personnel from Contract Research Organisation ƒ Expectations from inspections
and Contract Manufacturing Organisations as well as auditors
responsible for performing self-inspections or external audits Data Integrity and Digital Signatures
will also benefit from this course.
ƒ What exactly is an electronic signature?
ƒ Advanced vs qualified digital signature
ƒ Technical implementation
ƒ Change of workflows
ƒ Parallel processes
ƒ How to manage replacements

Data Integrity and Good Documentation Practice | 18 – 20 June 2024, Vienna, Austria
 Speakers

Handling Hybrid Records: Good Documentation Management and Control of Multilingual Documents
Practices for Linked Paper and Electronic Records (Data Integrity Expectations)

ƒ Chapter 4 and 21 CFR 11 regulations for linking signatures ƒ Part 1: Basics

to electronic records - Workbench
ƒ Are you saving the underlying electronic record? - Translation
ƒ Checks and technical controls to ensure the signature are - Synchronisation
linked to the record ƒ Part 2: Implementation and management
ƒ Common pitfalls in record - signature linking - Responsibilities
- GMP status
Second Person Review of Batch and Analytical - Versions
Records: Paper, Hybrid and Electronic Formats - Signatures
- Change Control
ƒ Importance of a second person review for Data Integrity
ƒ What will a reviewer review with paper, hybrid and
electronic records? Speakers
ƒ Training for second person review
ƒ Detection of poor documentation practices and Dr Bob McDowall
falsification McDowall Limited, UK
ƒ Risk-based second person reviews of records and audit Analytical chemist with nearly 50 years’ experience
trails including 15 years working in the pharmaceutical in-
dustry. Bob has been a consultant for nearly 30 years and has
been involved with computer validation for 35 years. Bob is the
writer of the Questions of Quality (LC-GC Europe) and Focus on
Workshop I: Quality (Spectroscopy) columns and is a member of the Editorial
Design of a Document Control SOP & Advisory Boards of several journals. He was a contributor to the
Workshop II: GAMP Good Practice Guide for Validation of Laboratory Comput-
Document Control Process Flow erised Systems and a contributor and reviewer of the GAMP
Guide on Records and Data Integrity and two associated Data
ƒ Develop an SOP for document control Integrity Good Practice Guides. He is the author of Data Integ-
ƒ Identify the dos and don‘ts for both paper and rity and Data Governance: Practical Implementation for Regu-
electronic records lated Laboratories.

Stephan Dresen, Ph.D.

How to Train Staff in Good Documentation Practice Daiichi Sankyo Europe GmbH, Germany
and Data Integrity Stephan Dresen is Executive Director / Head of Qual-
ity Controlat Daiichi Sankyo Europe in Pfaffenhofen.
ƒ Pre-requisites: Data Integrity policy with effective training Formerly he was Director Quality / Regional Head of Quality at
ƒ Procedure for good documentation practices is essential Warner Chilcott / Allergan. With more than 18 years of experi-
ƒ Options for training: read and understand, instructor led ence in leading positions within the pharma industry (Abbott/
training (ILT) and ILT with check for understanding AbbVie, Allergan, Corden Pharma) he was responsible for the
sites in Germany, Serbia and Greece. Also, he had been global
Data Integrity: Praxis Example of Implementation of strategic Business Sponsor for all QA/QC IT Systems. For multi-
the Requirements at a Pharma Site Based on Quality ple years he was Head of Quality for all External Operations in
Risk Management Principles Europe (TPM). Next to this he is Managing Director at
D|Consulting GmbH, developing and implementing pharmaceu-
tical and medical knowledge management systems.
Typical Documentation Failures and how to Avoid
them – Key Learning Points
Social Event
ƒ Learning from the worst: the FDA annual list of 483
observations On the evening of the first day, you
ƒ Identifying the top 5 documentation failures from the list are cordially invited to a social event.
ƒ Suggestions to avoid getting a citation in your facility This is an excellent opportunity to
share your experiences with col-
leagues from other companies in a
relaxed atmosphere.

Data Integrity and Good Documentation Practice | 18 – 20 June 2024, Vienna, Austria
 If the bill-to-address deviates from the specifica- Reservation Form (Please complete in full)
tions on the right, please fill out here:
Data Integrity and Good Documentation Practice, 18 – 20 June 2024, Vienna, Austria
____________________________________

____________________________________ Title, first name, surname

____________________________________
Department Company

____________________________________
Important: Please indicate your company’s VAT ID Number Purchase Order Number, if applicable

CONCEPT HEIDELBERG City ZIP Code Country

P.O. Box 101764
Fax +49(0) 62 21/84 44 34
Phone / Fax
D-69007 Heidelberg
GERMANY
E-Mail (Please fill in)

General terms and conditions CONCEPT HEIDELBERG reserves the right to change the materials, instructors, cellation or non-appearance. If you cannot take part, you have to inform us in Privacy Policy: By registering for this event, I accept the processing of my Perso-
If you cannot attend the conference you have two options: or speakers without notice or to cancel an event. If the event must be cancelled, writing. The cancellation fee will then be calculated according to the point of nal Data. Concept Heidelberg will use my data for the processing of this order,
1. We are happy to welcome a substitute colleague at any time. registrants will be notified as soon as possible and will receive a full refund of time at which we receive your message. for which I hereby declare to agree that my personal data is stored and pro-
2. If you have to cancel entirely we must charge the following processing fees: fees paid. CONCEPT HEIDELBERGwill not be responsible for discount airfare pe- In case you do not appear at the event without having informed us, you will have cessed. Concept Heidelberg will only send me information in relation with this
- Cancellation until 4 weeks prior to the conference 10 %, nalties or other costs incurred due to a cancellation. to pay the full registration fee, even if you have not made the payment yet. Only order or similar ones. My personal data will not be disclosed to third parties (see
- Cancellation until 3 weeks prior to the conference 25 %, Terms of payment: Payable without deductions within 10 days after receipt of after we have received your payment, you are entitled to participate in the con- also the privacy policy at http://www.gmp-compliance.org/eca_privacy.html). I
- Cancellation until 2 weeks prior to the conference 50 %, invoice. ference (receipt of payment will not be confirmed)! (As of January 2012). note that I can ask for the modification, correction or deletion of my data at any
- Cancellation within 2 weeks prior to the conference 100 %.
# Important: This is a binding registration and above fees are due in case of can- German law shall apply. Court of jurisdiction is Heidelberg. time via the contact form on this website.
Email
Date

Venue
Schlossallee 8

Registration

P.O.Box 10 17 64
VAT is reclaimable.

cate of participation.
1140 Vienna, Austria

Accommodation
ECA Members € 2,090
Phone +43/1/89110

APIC Members € 2,190

CONCEPT HEIDELBERG
ervation is recommended.

Fax +49(0)62 21/84 44 34

organisation of this event.
Non-ECA Members € 2,290

Phone +49(0)62 21/84 44-0

Conference language

69007 Heidelberg, Germany

[email protected]
www.concept-heidelberg.de
EU GMP Inspectorates € 1,145

[email protected].
[email protected]
Presentations/Certificate

Organisation and Contact

Tuesday, 18 June 2024, 9.00 – 18.00
(Registration and coffee 8.30 – 9.00)

Thursday, 20 June 2024, 8.30 – 13.00

+49(0)62 21/84 44 50, or per e-mail at

+49(0)62 21/84 44 24, or per e-mail at

Fees (per delegate, plus VAT)
Wednesday, 19 June 2024, 8.30 – 17.45

Doubletree by Hilton Vienna Schönbrunn

Ms Anne Günster (Operations Director) at

[email protected]

Ms Sonja Nemec (Organisation Manager) at

includes lunch on all days and all refreshments.

The official conference language will be English.

ECA has entrusted Concept Heidelberg with the

For questions regarding content please contact:

Via the attached reservation form, by e-mail or by fax

For questions regarding organisation etc. please contact:

download and print before and after the event. Please note

site. After the event, you will automatically receive your certifi-
there will not be any opportunity to print the presentations on
tion form/POG when you have registered for the course.

message. Or you register online at www.gmp-compliance.org.

Reservation should be made directly with the hotel. Early res-

that no printed materials will be handed out on site and that

rooms in the conference hotel. You will receive a room reserva-
The fee is payable in advance after receipt of invoice and

The presentations for this event will be available for you to

CONCEPT HEIDELBERG has reserved a limited number of

WA/09082023