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
Requirements for Cloud Services
9:00 Welcome note from Fleming • The world beyond functional requirements
• Instructions by a Fleming member • Open vs. closed systems (21CFR11 §11.30)
• Opening remarks from the trainer • Splitting into working groups
• Elaboration of data requirements for cloud services
9:10 SURVEY: What CSV/Data Integrity issues do in working groups
you struggle with in the Cloud? • Presentation of results
Meet & greet the trainer and participants, as well
as share your expectations, and major issues with 14:00 Data Migration & Interfaces
regard to this course and what you would like to • Interface validation vs. data verification
learn • System border definition
• Documentation of critical data flows
9:30 How does CSV support Data Integrity?
• Setting the scene for the training 14:40 Break
• Data integrity by design
• Data integrity assurance through CS assurance 15:10 PLENARY DISCUSSION:
• Cloud definitions & models 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 13:20 PLENARY DISCUSSION: Physical
participants & Logical Security in a GxP Cloud System
• What are/have been your major challenges?
9:00 WORKSHOP: Verification Methods • How did you/do you plan to overcome them?
• How to verify specific data requirements
• Splitting into working groups 13:40 System Overview Document
• Elaboration of test cases for specific data • System overview document/system description
requirements in working groups - EU requirements
• Presentation of results - PIC/S requirements
- FDA requirements
10:15 Break
14:00 Break
10:45 Iterative Prototyping & Agile Methods
• Waterfall method vs. iterative prototyping 14:20 WORKSHOP: System Periodic Review
• Agile methods • Splitting into working groups
• Validation when following alternative SW • Roles & responsibilities regulated company / CSP
development approaches • Elaboration of system periodic review activities in
working groups regarding
11:45 DISCUSSION - Computerized system validation status
- Data integrity
12:00 Lunch
- CSP compliance
• Presentation of results
13:00 Physical & Logical Security in a GxP Cloud
System 15:10 PLENARY DISCUSSION
• Physical access controls
• Logical access controls 15:30 End of Day 2
- Identity management
- User account management
- Authorization management
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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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