Data Integrity and Good

Documentation Practice
GMP-compliant instructions and records

SPEAKERS:

Bob McDowall
McDowall Ltd., UK

Stephan Dresen
Allergan Inc / Warner Chilcott
Deutschland GmbH

All participants get a free copy of the

current version of the ECA „Data Gov-
Wolfgang Schumacher ernance and Data Integrity for GMP
formerly F. Hoffmann- Regulated Facilities“ Guidance
La Roche

9 – 11 April 2019, Barcelona, Spain

LEARNING OBJECTIVES:
„„ Principles of Good Documentation Practice and
data integrity
„„ Instructions, blank forms and records – Life cycle and
data integrity considerations
„„ Good Documentation Practices for linked paper and
electronic records
„„ Life cycle of documents and data integrity issues
„„ GMP-compliant document change management
„„ How to perform Second Person Review of Batch Records
in different formats
„„ How to train staff in Good Documentation Practice and
data integrity
„„ Management and Control of multilingual Documents
„„ Typical documentation failures and how to avoid them

This education course is recognised for the ECA GMP Certification Programme „Certified Data Integrity Manager“.
Please find details at www.gmp-certification.eu
Data Integrity and Good Documentation Practice
9 – 11 April 2019, Barcelona, Spain

Objectives Programme

During this Course you will get to know the principles of Overview of the Training Seminar
Good Documentation Practices in the light of Data In-
tegrity requirements. You will learn Data Integrity Principles
„„ Basements of Data Integrity
„„ How to control blank forms and templates „„ Guidelines
„„ How to maintain data integrity for physical, hybrid „„ Implementation of Data Integrity Standards at a Side
and electronic records (Praxis Example)
„„ How to establish a compliant and pragmatic change „„ CARs Model (Critical Application Risks) – an imple-
control process mentation model based on Quality Risk Management
„„ How poor documentation practices and falsification
can be detected Current Inspection Observations and Their Potential
„„ How to train staff in Good Documentation Practice Resolution
and Data Integrity „„ Examples from current Inspections
„„ How multilingual documents can be managed and „„ Potential CAPAs on observations
controlled „„ Watch-Outs and defense packages
„„ How to avoid typical documentation failures „„ Inspectors expectations on industry from different
authorities: FDA, ANVISA, MHRA, German MoH …
Experts will show what you need to consider to maintain
GMP-compliant documentation systems throughout Why is control of blank forms important?
their life cycle. „„ Instructions and blank forms – Life cycle and data
integrity considerations
Background „„ FDA requirements for control from 1993 and 2016
„„ Process for creation of master templates
Despite numerous regulatory guidelines poor documen- „„ Process for operational use of blank forms
tation practice has become more and more a global „„ Reconciliation mechanisms
problem and in most cases it leads to severe violations of
data integrity principles. The citations regarding data in- Facilitated Discussion: Control of Templates and Blank
tegrity issues in FDA warning letters have been increasing Forms
dramatically over the past 3 years and also European
Regulatory Agencies are concerned about data integrity Records – Life Cycle and data integrity issues
failures in poor documentation not only in companies „„ GMP Record Lifecycle
located in far East but also within Europe. „„ Control Mechanisms
„„ Data Integrity for physical vs. electronic Records
Both FDA and UK’s MHRA have reacted to this situation „„ How to manage record copies without violating DI
by issuing guidances containing clear provisions regard- rules?
ing data integrity and documentation e.g. FDA’s CPG ob-
jective 3 which covers the laboratory data integrity audit GMP compliant document change management
or MHRA’s Guidance for Industry on Data Integrity. Also „„ How to establish a compliant and pragmatic change
WHO has published a guidance which provides provi- control process?
sions for data governance and contains expectations for „„ The GMP Document Roadmap
records in both paper and electronic form. „„ Document inventory and reconciliation
„„ Industry best practice for Record retention timelines
Target Audience – GMP requirements vs. Knowledge Management

This Education Course is designed for Managers and staff Advantages and Disadvantages of Document Manage-
from Manufacturing, QC/QA and Analytical Develop- ment Systems: Paper based - Hybrid – Electronic
ment Laboratories of pharmaceutical companies and API
manufacturers. Laboratory and QA personnel from Con- Electronic Document Management and Change Con-
tract Research Organisation and Contract Manufacturing trol Systems to Ensure Data Integrity
Organisations as well as Auditors responsible for per- „„ Data integrity expectations on an Electronic Docu-
forming self-inspections or external audits will also ben- ment Management System (EDMS) and Change
efit from this course. Control System
„„ Audit Trail Review / Log File Review
„„ Fundaments of a modern EDMS
„„ Traceability
„„ Mapping ALCOA principles on EDMS and Change
Control
„„ Expectations from Inspections
Data Integrity and digital signatures Management and Control of multilingual Documents
„„ What exactly is an electronic signature? (Data Integrity Expectations)
„„ Advanced vs qualified digital signature „„ Part 1: Basics
„„ Technical implementation –– Workbench
„„ Change of Workflows –– Translation
„„ Parallel processes –– Synchronisation
„„ How to manage replacements „„ Part 2: Implementation and Management
–– Responsibilities
Handling hybrid records: Good Documentation Prac- –– GMP status
tices for linked paper and electronic records –– Versions
„„ Chapter 4 and 21 CFR 11 regulations for linking signa- –– Signatures
tures to electronic records –– Change Control
„„ Are you saving the underlying electronic record?
„„ Checks and technical controls to ensure the signature Speakers
is linked to the record
„„ Common pitfalls in record-signature linking Dr. Bob McDowall, McDowall Limited,
Bromley, Kent, UK
Second Person Review of Batch and analytical records: Analytical chemist with over 40 years experi-
- paper, hybrid and electronic formats ence including 15 years working in the phar-
„„ Importance of a second person review for data maceutical industry and afterwards working
integrity for the industry as a consultant. Bob is an
„„ What will a reviewer review with paper, hybrid and ISO 17025 assessor and he has been involved with the
electronic records? validation of computerised systems for over 25 years and
„„ Training for second person review is the author of a book on the validation of chromatogra-
„„ Detection of poor documentation practices and phy data systems. He was also a contributor to the GAMP
falsification IT Infrastructure control & compliance and Lab System
„„ Risk based second person reviews of records and Validation 2nd edition Good Practice Guides. He is a
audit trails core member of the GAMP Data Integrity SIG.

Stephan Dresen, Ph.D., Warner Chilcott

Workshop: Deutschland GmbH/An Allergan Company,
Design of a Document Control SOP Germany
Stephan Dresen is Director Quality at Warn-
er Chilcott Deutschland GmbH / Allergan
How to train staff in Good Documentation Practice and plc. where he is responsible for the site in
Data Integrity Germany and global Sponsor for QA/QC IT Systems. Be-
„„ Pre-requisites: data integrity policy with effective fore that he was Head of Quality, External Operations
training (TPM). Besides that he is also Managing Director at
„„ Procedure for good documentation practices is D|Consulting GmbH, dealing with pharmaceutical and
essential medical knowledge management. He studied Chemistry
„„ Options for training: read and understand, instructor and Linguistics and got his Ph.D. from Trinity College in
led training (ILT) and ILT with check for understanding Dublin, Ireland

Data Integrity: Praxis example of implementation of Dr Wolfgang Schumacher, formerly

the requirements at a pharma site based on Quality F. Hoffmann-La Roche Ltd., Switzerland
Risk Management principles Dr Schumacher studied chemistry and
pharmacy. After entering Asta Medica, he
Typical documentation failures and how to avoid them headed different positions. In 2001 he joined
– key learning points F. Hoffmann-La Roche, Basle, where he was
„„ Analysis of FDA 483 and warning letter citations for Head of the department of Quality Computer Systems.
poor documentation practices Since August 2016 he works as an independent Pharma
„„ Identification of top 5 documentation failures consultant. He is a member of the ECA Advisory Board
„„ Ways to avoid them e.g. through changes in working and chairman of the IT Compliance Group, an interest
practice, training and technical controls group of the ECA Foundation.
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