ONLINE

LIVE TRAINING COURSE

Computerized
Systems
Validation, Data
Integrity & Cloud
Computing
in Pharma &
www.fleming.events

Biotech
14th - 16th February 2024
9:00 CET – 15:30 CET
Course Overview:
This course is a compilation of topics representing recent challenges related to CSV of cloud-based systems
in GxP regulated context, and how CSV relates to data integrity assurance. This course is meant to be an
advanced course on selected modern CSV methods with special consideration of aspects playing into
today’s omnipresent challenges around data integrity and cloud services.

Key Takeaways:
Learn Gain
how CSV can support data integrity tips for data migration & interfaces

Gain Master
insight into the recent inspection trends regulatory compliance of outsourced
around CSV and data integrity processes

Reveal Leverage
FDA and EU requirements for e-signatures/ COTS CSP specifications & CSP test
biometric signatures documentation

Understand Best practices

 what a data perspective means in physical & logical access controls in GxP
Cloud systems

Best practices
Discuss practices in IT Incident, Problem, and
data requirements for cloud services in a Change Management in a GXP Cloud
workshop Context

Practice Case study

system periodic review activities in a on implementation of a SaaS ERP System in
workshop a GxP Contextt

Get
insights into key aspects & processes to
consider in qualification of cloud service
providers

Key topics:
 CSV considerations around data integrity and  Data migration and interfaces
cloud-based systems  Physical & logical security in a GxP cloud system
 Inspection trends around CSV and data integrity  System periodic review
 Qualification of Cloud Service Providers  System overview document
 Service Level & Quality Assurance Agreements  IT incident & change management in a GXP
 Requirements for e-signatures/biometric context
signatures  Implementation of a SaaS ERP System in a GxP
 Taking a data perspective Context
 Data requirements for validation
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Training audience Training features
This Training Course is of particular interest to  Real-time, instructor-led course
Pharmaceutical & Biotech industry:  Discussions & workshops
 CSV consultants,  Digital Quality  Comprehensive digital course
experts, specialists  Master Data documentation
 Data integrity Management  Case studies & activities
consultants, experts,  Data Governance  Certificate of completion issued by the
specialists  Validation (CSV) trainer
 IT Quality  Cloud Service Providers
 IT Compliance  Cloud System
 Quality Assurance Implementation
 Quality Management Consultants

Meet the Training Leader:

Dr. Thierry Dietrich
pharm@dviser, Germany
Founder, Owner, Management Consultant
Dr. Thierry Dietrich served in leading and consulting positions within the pharmaceutical,
diagnostics, and medical devices industries for more than 20 years. He founded pharm@dviser
in 2016, and acts as management consultant. His areas of focus are data integrity, auditing of IT
suppliers and IT organizations, managing large IT projects in GxP regulated areas, validation of computerized
systems, as well as the building and optimization of quality management systems with focus on IT and
data quality. Thierry Dietrich was/is leader resp. member of several ISPE GAMP® SIGs. He also is the author
of numerous technical publications, co-author on data integrity related books, and speaker on technical
conferences.

Guest Speaker
Sinan Sahin
VQC Consulting GmbH, Germany
Computer Validation Manager, CSV-Consultant
As a Computer Validation Manager, the expert focuses on validation of computer systems in
regulated environments, data integrity, and GMP compliance in pharmaceutical companies.
In addition, Sinan Sahin focuses on developing (global) validation frameworks, providing CSV
training, conducting CSV and IT supplier audits and regular reviews. In this context, besides his extensive
range of experience and knowledge, he also draws on the numerous regulatory knowledge gained from the
regulatory frameworks. Additionally, the scope of his projects includes international IT projects and IT system
implementations. Sinan Sahin consults the pharmaceutical, chemical, and medical device industries on the
qualification and validation of computerized systems and equipment.

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 Day 1
14 February 2024

8:45 Login of remote participants 13:00 WORKSHOP: Defining Data

9:00 Welcome note from Fleming
• Instructions by a Fleming member
• Opening remarks from the trainer
9:10 SURVEY: What CSV/Data Integrity issues do
you struggle with in the Cloud?
Meet & greet the trainer and participants, as well
as share your expectations, and major issues with
regard to this course and what you would like to
learn
9:30 How does CSV support Data Integrity?
• Setting the scene for the training
• Data integrity by design
• Data integrity assurance through CS assurance
• Cloud definitions & models
Requirements for Cloud Services
• The world beyond functional requirements
• Open vs. closed systems (21CFR11 §11.30)
• Splitting into working groups
• Elaboration of data requirements for cloud services
in working groups
• Presentation of results
14:00 Data Migration & Interfaces
• Interface validation vs. data verification
• System border definition
• Documentation of critical data flows
14:40 Break
15:10 PLENARY DISCUSSION:
Topics of the day

10:00 Qualification of Cloud Service Providers 15:30 End of Day 1

(CSP)
• Outsourced services
• Aspects and processes to consider
• Roles & responsibilities
• Audit clause and inspection support
• CSP documentation packages

10:30 Break

11:00 Requirements for e-signatures/biometric

signatures
• U.S. FDA requirements around e-signatures/
biometric signatures
• EU requirements around e-signatures/biometric
signatures
• Technical challenges
- Record retention vs. business evolution (e.g.,
M&A)
- Record retention vs. IT landscape evolution

11:30 Taking the Data Perspective

• From a material perspective to a process
perspective
• What does taking a data perspective mean?

12:00 Lunch

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 Day 2
15 February 2024

8:45 Online meeting room opens for login of
participants
9:00 WORKSHOP: Verification Methods
• How to verify specific data requirements
• Splitting into working groups
• Elaboration of test cases for specific data
requirements in working groups
• Presentation of results
10:15 Break
10:45 Iterative Prototyping & Agile Methods
• Waterfall method vs. iterative prototyping
• Agile methods
• Validation when following alternative SW
development approaches
11:45 DISCUSSION
12:00 Lunch
13:00 Physical & Logical Security in a GxP Cloud
System
• Physical access controls
• Logical access controls
- Identity management
- User account management
- Authorization management
13:20 PLENARY DISCUSSION: Physical
& Logical Security in a GxP Cloud System
• What are/have been your major challenges?
• How did you/do you plan to overcome them?
13:40 System Overview Document
• System overview document/system description
- EU requirements
- PIC/S requirements
- FDA requirements
14:00 Break
14:20 WORKSHOP: System Periodic Review
• Splitting into working groups
• Roles & responsibilities regulated company / CSP
• Elaboration of system periodic review activities in
working groups regarding
- Computerized system validation status
- Data integrity
- CSP compliance
• Presentation of results
15:10 PLENARY DISCUSSION
15:30 End of Day 2

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 Day 3
16 February 2024

8:45 Online meeting room opens for login of

participants

9:00 IT Incident, Problem, and Change

Management in a GXP Context
• IT incident management vs. deviation management
• IT problem management vs. CAPA
• IT change management vs. change control

9:45 CASE STUDY: Decision Tree for the handling

of IT related unplanned events

10:10 Auditing GxP Computerized Systems

• Inspection trends around CSV and data integrity
• IT supplier auditing
• Internal auditing around CSV and data integrity

11:00 Break

11:30 WORKSHOP: Auditing Data Integrity in a

Cloud Context
• How to audit data integrity in a cloud context?
• Splitting into working groups
• Elaboration of the topic in working groups
• Presentation of results

12:30 Lunch

13:30 CASE STUDY: Implementation of a SaaS ERP

System in a GMP Context

14:15 CASE STUDY: Implementation of a PaaS

WMS System in a GDP Context

15:00 DISCUSSION & KEY TAKEAWAYS

15:30 End of Training

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