GMP Certification Programme

Certified Computer Validation Manager

Speakers
Computerised System Validation
- Introduction to Risk Management
Frank Behnisch
CSL Behring
- The GAMP® 5 Approach
23 April 2024 and 24-26 April 2024, Berlin, Germany

Yves Samson
Kereon

Dr Robert Stephenson
Rob Stephenson Consultancy

Save up
to
€ 590,-
by boo
k
both co ing
urses!

Learn How to Plan, Implement and Document Effectively

Computer Validation Activities

Highlights
ƒ The new GAMP® 5 Second Edition
ƒ The EU GMP Guide Annex 11
ƒ 21 CFR Part 11
ƒ The GAMP® 5 Lifecycle
- Software Categorisation
- Specifications
- Verification / Testing
ƒ Practical Risk Management – ICH Q9 and FMEA Methodology
ƒ Validation Planning
ƒ Change Control & Test Incident Management
ƒ Validation Documentation
ƒ Presentation to Inspectors
ƒ Data Integrity Considerations for CSV
ƒ Up to 10 Workshops / Interactive Sessions

Including implications of
EU GMP Annex 11 “computerised systems”
Programme “Computerised System Validation: Introduction to Risk Management”

Objectives Workshop: Risk Management Applied to a

ƒ Get to know the current risk management approaches of Computerised System
ICH Q9 and GAMP® 5 2nd Edition
ƒ Become familiar with the use of the latest methods and ƒ High Level and System Risk Assessment
tools for risk analysis when validating computerised ƒ Evaluating identified risks
systems ƒ Controls to mitigate unacceptable risks
ƒ Learn how the activities involved in the validation of
computerised systems can be controlled efficiently by
means of risk management
ƒ In 3 workshops you can see how these procedures are Workshop: Functional Risk Assessment
applicable Applied to a Control System

ƒ How to document a FRA

Background ƒ
ƒ
Classification of risks into H, M, L
What are the conclusions from the risk assessment?
Current GMP regulations and guidelines (EU-GMP Guide Annex
ƒ What options do you have to mitigate (reduce) the
11 ‘Computerised Systems’, ICH Q9, GAMP® 5 2nd Edition, ASTM
higher risks?
E2500-20) focus more and more on the topic of risk manage-
ƒ Using the output to determine verification tasks
ment. However, the regulations do not offer much concrete ad-
vice on how their principles should be translated into practice
during the validation and operation of computerised systems.
Therefore, it is the aim of this course to provide you with prac-
An Introduction to Risk Ranking
tice-oriented guidance in performing this task. ƒ What is risk ranking?
ƒ How is it carried out?
Target Audience ƒ
ƒ
How is it documented?
A few useful applications
This Training is directed at employees from Production, Quality
Control / Quality Assurance, Engineering, IT who have to deal
with risk assessment and risk management in the field of com- Workshop: Applying Risk Ranking to
puterised system validation. Determine System Remediation Priorities

ƒ How is severity determined?

Programme ƒ How can scales be created?
ƒ Ranking the risks
Introduction – What Do You Want From This Day? ƒ Developing a risk-based action plan
ƒ Capturing delegates expectations
ƒ Sharing and reducing to key points in groups
ƒ Sharing with all delegates and tutors
Your Benefits
An Introduction to Risk Management Internationally Acknowledged
(Including ICH Q9) Certificate from ECA Academy
ƒ Definition of “Quality Risk Management” The EU GMP Guide requires: „…
ƒ Principles of Quality Risk Management All personnel should be aware of
ƒ Application of the principles in validation the principles of Good Manufacturing
Practice that affect them and receive
ƒ Methods of assessing and controlling risk initial and continuing training,…“.
ƒ Regulatory expectations for risk management This is why you receive an acknowledged
participant certificate, which lists the
contents of the course in
Risk Management the GAMP® 5 Way detail and with which you document
your training.
ƒ The importance of Risk-based Decision Making
ƒ How the GAMP 5 Risk Management Approach aligns with
ICH Q9 This Training Course is recognized for the
GMP/GDP Certification Scheme
ƒ The 5-Steps you will need to follow described in detail
ƒ Risk Management throughout the System Lifecycle Building on your education the ECA GMP/GDP
ƒ Short workshop on Risk Identification and Risk Analysis certification programmes provide you with the appro-
piate supplement to acquire this qualification. This
training course is the first element for your additional certification.
Risk Assessment the GAMP® 5 Way Simply choose any three courses within the programme according
to your professional interest. Your certificate is then valid for two
ƒ The simple GAMP® 5 Risk Assessment Method years. To renew it, you can pick any training from the ECA courses
ƒ Assessment Scales for computerised systems that work and conferences list within that two-years period – allowing you to
broaden your knowledge in GMP and GDP compliance. Please find
ƒ Functional Risk Assessments and Risk Reduction Strate- more information at [Link]
gies
ƒ Using risk to determine Test Rigour

Computerised System Validation: Introduction to Risk Management

Programme “Computerised System Validation – The GAMP® 5 Approach”

Objectives Regulatory Framework Overview

Why you should attend this training: ƒ GxP: Regulated Good Practices
ƒ You will systematically be introduced to the principles and ƒ EudraLex
methods of the validation of computerised systems - Relevant Regulatory Framework for CSV Purposes
(according to GAMP®) ƒ US GxP Regulations
ƒ You will learn the skills to plan, implement and document ƒ Industry Standards
effectively validation activities for computerised systems
and to assess them with respect to their GxP compliance Annex 11 “Computerised Systems” to European GMP
ƒ In workshops / interactive sessions you can see how the
theoretical foundations will apply practicable ƒ General principles
ƒ Project phase
Background ƒ
ƒ
Operation
ERES requirements
Computerised systems are a central factor determining work se- ƒ Annex 11 vs 21 CFR Part 11
quences in the pharmaceutical industry. Their use increases pro- ƒ How can you implement it?
duct safety and saves time and costs of manual intervention.
This creates the requirement and necessity, however, to validate
all computerised systems which can influence the quality of Workshop: Self Evaluation of CSV
pharmaceutical products. Regulatory Compliance

The basis of the Training will be the current requirements for the
validation of computerised systems like GAMP® and their GxP- The GAMP® 5 2nd Edition: A Risk-Based Approach to
oriented application in practice. Compliant GxP Computerised Systems
Experts from the pharmaceutical industry and from the GAMP® ƒ Applicability
Committee will show you efficient ways to validate your compu- ƒ GAMP® 5 Key Principles
terised systems. ƒ Life Cycle / ASTM E2500-13 / V-Model
ƒ Guide Structure
Target group ƒ Risk Management according to ICH Q9
This Training is directed towards specialists and executives in
Data Integrity Considerations for CSV
the pharmaceutical industry entrusted with the planning, imple-
mentation and evaluation of the validation of computerised sys- ƒ What data are relevant?
tems. ƒ ALCOA+: Data Integrity criteria
ƒ Paper vs hybrid vs electronic systems
ƒ Data integrity requirements for CSV projects
Programme
Specifying Requirements
Introduction – What the Participants Expect ƒ Importance of Requirements Specification (RS)
An open session capturing the expectations of the delegates. ƒ RS Scope and Contents
ƒ Roles & Responsibilities
Validation Overview ƒ Requirements Good Practices
ƒ What do we mean by Validation? ƒ POLDAT
ƒ Validation and Qualification
ƒ Organising and Planning
GAMP® 5 Software Categories
ƒ Good Documentation Practice ƒ System Structure
ƒ Specification & Verification ƒ Software Categories 1, 3, 4, 5
ƒ System Inventory ƒ End User Applications
ƒ System Description ƒ User View vs IT Perspective

Computerised Systems in Practice

Workshop: Software Categorisation According
ƒ Definition of a Computerised System to GAMP® 5
ƒ Scope of CSV (Computerised System Validation)
- Laboratory Equipment
- Automation / Process Control
- Facility Management
- GxP Applications – GCP / GLP / GMP / GDP / GVP
- IT / OT Infrastructure

Computerised System Validation – The GAMP© 5 Approach

Functional Specifications – Building the Bridge Testing of GxP Systems
ƒ Importance of URS – FS linking ƒ Verification vs Validation Terminology
ƒ FS Scope and Contents ƒ Software testing
ƒ Roles & Responsibilities ƒ Acceptance testing / Factory acceptance test (FAT) /
ƒ FS and FRA Site acceptance test (SAT)
ƒ FS Good Practices ƒ Qualification testing
- Installation qualification (IQ) / configuration testing
- Operational qualification (OQ) / functional testing
Workshop: Specifying Requirements - URS vs. - Performance qualification (PQ) / requirements testing
FS ƒ Good Testing Practice
ƒ Management of test environment
ƒ Verification of data migration activities
Design Specification ƒ Optimising the test strategy
ƒ CS – Configuration Specification
ƒ Detailed Specification Test Incident Management
- SDS – Software Design Specification ƒ Test incident management overview
- SMS – Software Module Specification ƒ What is a test incident?
- HDS – Hardware Design Specification ƒ Test incident management process
- NDS – Network Design Specification ƒ Taking a risk-based approach

Requirement Traceability
Workshop: Test Incidents
ƒ Regulatory expectation vs Good Engineering Practice
ƒ Vertical Traceability / Horizontal Traceability
ƒ How to trace? - Embedded Traceability / Traceability
Matrix Change and Configuration Management During the
Project Phase
Design Review … More Than a Milestone: A Process
ƒ Regulatory requirements
ƒ GAMP® 5 recommendation on ‘Design Review’
ƒ Configuration management
ƒ Functional & technical design review
ƒ Change management
ƒ Scaleability of the review activities
ƒ Responsibilities
ƒ Design review: a life cycle supporting process
ƒ Recommendation
ƒ Design review documentation
- When to start?
ƒ From ‘Design Review’ to ‘Periodic Evaluation’
- Areas of concern
Validation Planning
ƒ CSV: A Life cycle approach embedded into the QMS Workshop: Change Management
ƒ Validation Master Plan
ƒ Qualification & Validation on Project / System Level
- Qualification / Validation Plan CSV – Specific Aspects: Automation
- Supplier Assessment / Supplier Management
- Risk Management ƒ System Overview / Specifications
- Documentation ƒ GAMP® 5 and risk analysis
- Verification ƒ Findings & consequences
- Supporting Processes / System Release
Validation Reporting and Handover to Operation
Workshop: Validation Planning ƒ Linking the Validation Plan and Report
ƒ Key documents
ƒ Validation summary reports
ƒ Handover to Operation

CSV: Presentation to Inspectors

ƒ Managing the inspection
ƒ What inspectors want to see
ƒ Warning Letters and 483s
ƒ Inspection experiences
ƒ Lessons to learn

Computerised System Validation – The GAMP© 5 Approach

Conference language
The official conference language will be English.
Speakers
Presentations/Certificate
The presentations for this event will be available for you to download Frank Behnisch
and print before and after the event. Please note that no printed ma- CSL Behring GmbH, Germany
terials will be handed out on site and that there will not be any oppor-
tunity to print the presentations on site. After the event, you will auto- Frank is Senior Manager Project Engineering at CSL Behring
matically receive your certificate of participation. GmbH in Marburg, Germany. He is member of the GAMP® D-A-
CH „steering committee“ and chairman of a GAMP® Special In-
Organisation and Contact terest Group (SIP) for “Small Systems”.
ECA has entrusted Concept Heidelberg with the organisation of this
event.
CONCEPT HEIDELBERG
P.O. Box 10 17 64 Yves Samson, Kereon AG
69007 Heidelberg, Germany Basel, Switzerland
Phone +49(0)62 21/84 44-0
Fax +49(0)62 21/84 44 34 Yves joined the industry where he served as project and site
info@[Link] engineer automation. In 2002, he founded Kereon AG. He is
[Link] member of GAMP® Europe Steering Committee, co-founder
For questions regarding content please contact: and chairman of GAMP® Francophone and edited the French
Dr. Andreas Mangel (Operations Director) at
version of GAMP® 4 / 5. Membership: Active member of the
+49(0)62 21/84 44 41, or at
GAMP working group ‘IT Infrastructure Compliance and Con-
mangel@[Link].
trol’ / ECA “DI & IT Compliance Group”.

For questions regarding organisation please contact:

Mr Ronny Strohwald (Organisation Manager) at
+49(0)62 21/84 44 51, or at Dr Robert Stephenson
strohwald@[Link]. Rob Stephenson Consultancy, UK

Rob joined Pfizer Sandwich UK in 2000 as member of their

This could be of interest for you as well Quality Unit operating within the IT group. As a long-standing
Would you like to train a larger group of participants in your member of the GAMP Europe Steering Committee Rob has con-
company? tributed material to GAMP® 5 and the ISPE GAMP Good Prac-
We offer practice-oriented GMP/GDP training courses on: tice Guide on “A Risk-Based Approach to Operation of GxP Com-
ƒ Basic GMP puterized Systems” for which he was co-leader.
- APIs (ICH Q7)
- Medicinal Products
- Biopharmaceuticals
ƒ Quality Assurance Social Event
ƒ Quality Control On Wednesday evening, you are cordial-
ƒ Validation/Qualification ly invited to a social event.
ƒ Regulatory Affairs This is an excellent opportunity to share
ƒ Sterile Manufacturing your experiences with colleagues from
ƒ IT / Computer Validation other companies in a relaxed atmos-
ƒ Good Distribution Practice (GDP) phere.
ƒ Data Integrity
ƒ Packaging
ƒ Medical Devices
ƒ Technical Operations

You will find a time schedule for each training course at https://
[Link]/training/gmp-gdp-in-house-trainings.
PE/21022024
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ECA Training Courses
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Computerised System Validation: Computerised System Validation –
____________________________________ Introduction to Risk Management The GAMP® 5 Approach
23 April 2023 24-26 April 2024
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ECA Members € 990

Accommodation
ECA Members € 2,090
APIC Members € 2,190
APIC Members € 1,090
HYPERION Hotel Berlin

The GAMP® 5 Approach

The GAMP® 5 Approach

Phone +49 (0)30 236250 0

Non-ECA Members € 1,190

Non-ECA Members € 2,290

EU GMP Inspectorates € 595
All times mentioned are CEST.

EU GMP Inspectorates € 1,145

ECA Members € 2,690

Computerised System Validation:
Computerised System Validation:

APIC Members € 2,790

Introduction to Risk Management
Introduction to Risk Management

Computerised System Validation –

Computerised System Validation –

Fees (per delegate plus VAT)

E-Mail: [Link]@[Link]

Non-ECA Members € 2,890

Dates of the Training Courses

Friday, 26 April 2024, 08.30 h – 16.00 h

Save money and book both courses:

and all refreshments. VAT is reclaimable.

Tuesday, 23 April 2024, 09.00 h – 18.00 h

EU GMP Inspectorates € 1,445

Thursday, 25 April 2024, 08.30 h – 17.30 h
(Registration and coffee 08.30 h - 09.00 h)
Wednesday, 24 April 2024; 09.00 – 17.30 h
(Registration and coffee 08.30 h - 09.00 h)

lunch and all refreshments. VAT is reclaimable.

each day and all refreshments. VAT is reclaimable.

with the hotel. Early reservation is recommended.

of rooms in the conference hotel. You will receive a
of invoice and includes conference documentation,
of invoice and includes conference documentation,

for the course. Reservation should be made directly

of invoice and includes conference documentation, 4
lunches, social event including dinner on Wednesday,
The conference fee is payable in advance after receipt
The conference fee is payable in advance after receipt
The conference fee is payable in advance after receipt

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