GMP Certification Programme
Certified Data Integrity Manager
Speakers
Lab Data Integrity
A Practical Approach for Generating and Auditing
Laboratory Records
Dr Christopher Burgess
Chairman of the ECA Analytical
Quality Control Working Group
Live Online Training on 05 - 07 December 2023
Dr Bob McDowall
Member of the ECA IT Compliance
Interest Group
Meeting Global Regulatory Concerns
Highlights
Laboratory Data & Results
- EU and US GMP Requirements
- MHRA and WHO Data Integrity Documents
- FDA Guidance Documents
- Inspection Findings: 483 and Warning Letters
Principles of Data Management
- Understanding and Applying ALCOA+ Principles to Laboratory Data
- Second Person Review of Analytical records
Requirements for Raw Data Integrity for
- Paper Records
- Hybrid Systems
- Electronic Systems incl. ELNs
On-site and Remote Audits of Analytical Records
Data Transformation: How to Identify and Handle Transcription Errors
Collation and Reporting of Results
All participants get free access to the current
version of the ECA „Data Governance and Data
Integrity“ Guidance.
Programme
Objective The emphasis of all regulators is on the ALCOA principles to out-
line regulatory expectations for ways to ensure the integrity of
The learning objectives are firstly, understand the data integrity data over the life cycle.
requirements of a GMP regulated laboratory in Pharmaceutical
organisations and contract labs and secondly, how laboratory The Live Online Training focuses on three types of records that
personnel can ensure compliance and be able to defend their po- can be found in analytical laboratories working to GMP: paper,
sitions. Records generated by three processes will be taken hybrid computerized system and electronic workflows with
through the presentations and workshops: paper only with re- electronic signatures. Through presentations, workshops and
cords maintained in a laboratory notebook or controlled sheets, Q&A sessions attendees are taken through the process from
hybrid system with signed paper records with underlying elec- analysis to generation of results to understand Data Integrity is-
tronic records and an electronic system using electronic signa- sues.
tures. Second person review is a critical process that needs to be
thorough and effective to ensure that data issues are picked up
and resolved. Target Audience
The auditing part of the Live Online Training will develop the un- This Live Online Training will be of significant value to:
derstanding of what is required for a data integrity on-site or re- Managers and scientists from Quality Control and
mote audit of a laboratory computerized system and then de- Analytical Development Laboratories wanting to
velop the principles, based mainly on workshops and Q&A understand the Data Integrity and audit process
session, of how to audit hybrid and electronic laboratory sys- Quality Assurance personnel
tems. The scope of auditing (on-site and remote) a system for Contract Research Organisation and Contract
data integrity will be developed during the training along with a Manufacturing Organisation laboratory and QA personnel
risk based prioritisation of the key areas to focus audit attention Auditors (internal and external) responsible for assessing
on. In preparation for the final sessions there will be workshops laboratory quality and Data Integrity
dealing with specific data integrity topics.
Background Programme Part 1, 05/06 December 2023
Establishing the Controls for Laboratory
Data Integrity is currently the major concern with both the FDA Data Integrity
and European Regulatory Agencies. Many FDA warning letters
and EU GMP inspections have highlighted major data integrity
failures at companies globally. The regulatory concern has been GMP Regulations Impacting Laboratory Data and
responded by the FDA issuing Compliance Program Guide (CPG) Results
7346.832 that covers Pre-Approval Inspections. This document
became effective in May 2012 after Agency inspectors received EU GMP requirements
training in Data Integrity where they focus on computer systems MHRA and WHO Data Integrity Guidances
and not the paper output. The CPG objective 3 covers the labora- FDA GMP requirements
tory data integrity audit. FDA Guidance documents OOS, Inspection of QC labs
Inspection findings 483 and warning letters
Since 2015, various regulatory authorities have published data Defining Data Integrity, “complete data” and „raw data“
integrity guidance documents e.g.
Principles for the Generation of Data
MHRA: 2 versions of a GMP guidance in 2015 and a GXP
guidance in 2018 Observational tests and instrument tests
WHO: two guidance documents in 2016 and 2021. The Training of staff
2016 version is more comprehensive and contains the Qualified analytical instruments and validated software
best description of ALCOA criteria in any regulatory Integrity issues
guidance. Application of ALCOA+ principles
FDA: issued an interpretation of cGMP about data integri-
ty in a Q&A format and
PIC/S: published their final version of PI-041 guidance in WORKSHOP I:
2021. Generation of Data
Industry bodies have also been active with the GAMP Forum What are the requirements for raw data integrity?
publishing a Records and Data Integrity Guide in 2017 and three Three scenarios covering
Good Practice Guides. APIC and PDA have issued guidance docu- - a paper system
ments on the subject. - a hybrid system
- a client server electronic system
Finally, ECA have issued a Data Governance and Data Integrity
Guide that delegates will get a free electronic copy of.
Lab Data Integrity - A Practical Approach for Generating and Auditing Laboratory Records | Live Online Training on 05 - 07 December 2023
Processing and Reporting of Data WORKSHOP V:
Electronic Signature Auditing
Paper / hybrid based systems
Networked systems with electronic records and signa- Use of electronic signatures can mask some Data Integrity
tures issues
Calculations and transformation of data manually and by Can the attendees find what those issues are?
computer applications Feedback from the teaching team
Application of ALCOA+ principles to the process
Calculating the reportable value and comparison with the
specification WORKSHOP VI:
Paper processes versus electronic processes Risk Assessment and Prioritisation
Linkage with out of specification investigations (OOS)
So much to do but so little time – risk management in
practice
WORKSHOP II: When conducting a Data Integrity audit which areas
Processing and Reporting of Data within a pharmaceutical quality system will be the focus?
Feedback from the teaching team
Reviewing an analytical record
Scenario covering paper-based record and an electronic
system WORKSHOP VII:
Audit of an Excel Spreadsheet
Reviewing Data
Attendees will be given an example of a spreadsheet
Role of the second person review What questions need to be asked to determine if there is
Determination that the reportable result is correctly sufficient Data Integrity and control?
calculated Feedback from the teaching team
WORKSHOP III: WORKSHOP VIII:
Data Review of an Excel Template Auditing a Hybrid Standalone System
A laboratory system is used in hybrid mode
Collation and Reporting Results What questions should the auditor ask to determine if
there are any data integrity problems?
Role of the second person review Feedback and discussion with the teaching team
Determination that the reportable result is correctly
calculated
Identification and correction of errors for paper and WORKSHOP IX:
electronic systems Auditing a Networked Laboratory System –
Do you have complete data? Audit Trail Review
Review of audit trail entries is a key data integrity require-
WORKSHOP IV: ment of Annex 11
Paper, Hybrid and Electronic Reporting Attendees will review the printout of an audit trail to
Processes determine if there any data integrity issues to be raised?
Can the attendees find what those issues are?
Discussion of the strengths and weaknesses of reporting Feedback and discussion with the teaching team
processes
WORKSHOP X:
Programme Part 2, 06/07 December 2023 Preparing for the Data Integrity Audit
Self Inspections and Audits to confirm Effective
Data Integrity Controls Preparation for a remote audit - what can you read?
Requesting the Site Master File
Requesting documents
Data Integrity Self Inspections and On-site and Handling time zone differences
Remote Audits for Hybrid and Electronic Systems What video conferencing system will you use?
Observations and findings
Remote audits: practicalities, limitations and problems
Lab Data Integrity - A Practical Approach for Generating and Auditing Laboratory Records | Live Online Training on 05 - 07 December 2023
Speakers
WORKSHOP XI:
Conducting a Remote Data Integrity Audit
Remote laboratory tour - what are you allowed to see?
On-line access to networked computer systems
Access to standalone systems?
Viewing documents on-line
Screens for the remote audit and taking notes
WORKSHOP XII:
Reviewing the Follow up Responses from a Remote
Data Integrity Audit
Access to documents after the audit
Reviewing responses to audit findings
Resolution of audit findings with evidence
Review of the Course and Key Learning Points
Speakers
Dr Christopher Burgess
Burgess Analytical Consultancy Ltd., UK
Chairman of the ECA Analytical Quality
Control Working Group
He is a Chartered Chemist and has more than 46 years experience in the
pharmaceutical industry initially with Glaxo in Quality Assurance and
Analytical R&D and then 26 years in international consultancy. He is a
“Qualified Person” in the European Union. He was appointed to the Unit-
ed States Pharmacopoeia’s Council of Experts 2010 to 2020 and re-elect-
ed for the 2020 to 2025 cycle. He is a visiting professor of the University
of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS).
In addition, he is the chairman of the ECA Analytical Quality Control
Group and a member of the Extended board of the European Compliance
Academy Foundation. He is also a member of the USP Joint Sub Commit-
tees entrusted to produce a new General Chapter <1220> on Analytical
Procedure Lifecycle and revised General Chapter <1058> on Analytical
Instrument Qualification.
Dr Bob McDowall
R D McDowall Limited, UK
Member of the ECA IT Compliance Interest Group
Analytical chemist with 50 years’ experience including 15 years working
in the pharmaceutical industry. 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
Quality (Spectroscopy) columns and is a member of the Editorial Advi-
sory Boards of several journals. He was a contributor to the GAMP Good
Practice Guide for Validation of Laboratory Computerised Systems and a
contributor and reviewer of the GAMP Guide on Records and Data Integ-
rity and two associated Data Integrity Good Practice Guides. He is the
author of Data Integrity and Data Governance: Practical Implementation
for Regulated Laboratories.
Dates of the Live Online Training Organisation and Contact
ECA has entrusted Concept Heidelberg with the organisation
Part 1: Establishing the Controls for Laboratory of this event.
Data Integrity
Tuesday, 05 December 2023, 09.00 h - 16.15 h CET CONCEPT HEIDELBERG
Wednesday, 06 December 2023, 09.00 h - 12.30 h CET P.O.Box 10 17 64
69007 Heidelberg, Germany
Part 2: Self Inspections and Audits to Confirm Effective Phone +49(0)62 21/84 44-0
Data Integrity Controls Fax +49(0)62 21/84 44 34
Wednesday, 06 December 2023, 13.30 h - 16.30 h CET
[email protected] Thursday, 07 December 2023, 09.00 h - 16.30 h CET www.concept-heidelberg.de
Part 1 & Part 2: For questions regarding content please contact:
Tuesday, 05 December 2023, 09.00 h - 16.15 h CET Ms Anne Günster (Operations Director) at
Wednesday, 06 December 2023, 09.00 h - 16.30 h CET +49(0)62 21/84 44 50, or at
Thursday, 07 December 2023, 09.00 h - 16.30 h CET
[email protected].
Technical Requirements For questions regarding organisation please contact:
We use WebEx for our live online training courses and webinars. At Ms Marion Grimm (Organisation Manager) at
https://www.gmp-compliance.org/training/online-training-techni- +49(0)62 21/84 44 18, or at
cal-information you will find all the information you need to partici-
[email protected].
pate in our trainings and you can check if your system meets the nec-
essary requirements to participate. If the installation of browser
extensions is not possible due to your rights in the IT system, please Internationally Acknowledged Certificate from
contact your IT department. WebEx is a standard nowadays and the ECA Academy
necessary installation is fast and easy.
The EU GMP Guide requires: „… All personnel should be aware of the
Fees (per delegate, plus VAT) principles of Good Manufacturing Practice that affect them and re-
Part 1: Establishing the Controls for Laboratory Data Integrity ceive initial and continuing training,…“. This is why you receive an ac-
ECA Members € 1,290 knowledged participant certificate, which lists the contents of the
APIC Members € 1,390 seminar in detail and with which you document your training.
Non-ECA Members € 1,490
EU GMP Inspectorates € 745
The conference fee is payable in advance after receipt of invoice. This Training Course is recognized for the
GMP/GDP Certification Scheme
Part 2: Self Inspections and Audits to Confirm Effective Data
Integrity Controls Building on your education the ECA GMP/GDP certification pro-
ECA Members € 1,290 grammes provide you with the appropriate supplement to acquire
APIC Members € 1,390 this qualification. This training course is the first element for your ad-
Non-ECA Members € 1,490 ditional certification. Simply choose any three courses within the
EU GMP Inspectorates € 745 programme according to your professional interest. Your certificate
The conference fee is payable in advance after receipt of invoice. is then valid for two years. To renew it, you can pick any training from
the ECA courses and conferences list within that two-years period –
Save up to 400 € by booking Part 1 & Part 2 allowing you to broaden your knowledge in GMP and GDP compli-
simultaneously: ance. Please find more information at www.gmp-certification.org.
ECA Members € 2,380
APIC Members € 2,480
Non-ECA Members € 2,580
EU GMP Inspectorates € 1,290
The conference fee is payable in advance after receipt of invoice.
Registration
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Presentations/Certificate
The presentations will be made available to you prior to the Live
Online Training as PDF files. After the event, you will automatically
receive your certificate of participation.
Conference language
The official conference language will be English.
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Lab Data Integrity - Live Online Training
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