We can help in in many Compliance related training. GDP, CAPA, Change Control, QSIT, Calibration, Qualification, Validation, CSV, CFR 820, CFR 211, CFR 210, 21 CFR Part11, Data Life Cycle, SDLC, Cloud Validation, Remediation, GAP Assessment

1. SPEAKER:
KALPESHKUMAR
VAGHELA
Time to Sharpen the skill and be worry free
ADDRESS
A9 Triloknagar Society, Gotri-Vasna Link Road, Vadodara
390021, Gujarat, India.
CONTACT US
Infra Control Systems | +91 9825047998; +918320551508 |
www.infraics.in
LIVE WEBINAR COURSE ON
COMPUTER
SYSTEM
VALIDATION
Add a brief description of the event series
here

2. RSE CONTENT
1. BASIC OF VALIDATION AND
QSIT COMBINED
• Why the need for Validation came in
to picture?
• Benefits of Validation
• Validation Definition
• Formation of Validation Team and
their responsibility
• Brief Details of Predicate Rules
CFR211/210
• QSIT
• Marketing is all P and Compliance is
also all P
• Change Control, CAPA, Incidence
and Some SOP
•
2. GAMP 5 ON BOTTOM PART
• GAMP5 Driver
• Patient Safety- product Quality-
Data Integrity
• CQA-CPP
• QbD Systems
• SDLC Life Cycle
• Vendor Qualification, SLA
• Why SME
• Software and Hardware category
• Network QUALIFICATION
• Difference between Qualification
and Validation
• Why to Calibrate?
• Data Life Cycle and GxP work flow
Needs to be focused.
• Types of Validation Prospective,
Concurrent and Retrospective.
3. 21 CFR PART 11 COMPLIANCE
IN DETAILS, DATA INTEGRITY
AND SECURITY. BASIC AND
ADVANCE TWO SESSION
• Main points
• Legacy System
• Open System
• Close System
• Electronic Records
• Hybrid Systems
MAKE IT YOURS
• Electronic Signature
• Digital Signatures
• Biometric
• Black box
• White box
• Patch Management
• Periodic Review
• Audit Trail and Audit Trail review
• Data backup – Restoration, Archival- Retrieval and data
Retention.
• Annex 11
4. DATA INTEGIRTY AND COMMON ISSUES
• Data Integrity, Data Life Cycle, Data Governance
• Raw, meta data, Static, Dynamic Data, Structured, Unstructured
Data, Active, Passive data
• Data Integrity Part, Cloud Validation
• ALCOA+ + Is about Data Life Cycle
5. RISK ASSESSMENT
• Basic Understanding
• Various types of Risk Assessment method
• Risk Assessment Sod, RPN no.
• Selecting and qualifying the right vendor – Risk Based Approach as
per GAMP category
• Example
• Benefit of risk assessment in large project
• Data Integrity How to control?
6. CLOUD VALIDATION
• What is cloud?
• Types of Cloud
• IaaS, PaaS, SaaS
• RTO-RPO
• Cloud Vendor Selection
• SLA
• Cloud Validation Points
• Benefit of Cloud.
• Risk Associated with cloud
“LEADERS
NEVER
STOP
LEARNING”
- -

3. • CONTACT US
+919825047998
+918320551508
infraics@gmail.com
+919825047998
+918320551508
KALPESHKUMAR VAGHELA
KALPESHKUMAR
VAGHELA
KVSTECHNOLOGIESKRV
7. VALIDATION DELIVERABLES
• This Session will be in Multiple Part.
• Computer Validation as per GAMP5
• CSV Deliverable
• SDLC Life Cycle Phase How to address
• User Requirement Specifications, Why to Write meaningful
specifications/requirements (URS)
• Initial Risk Assessment- Gxp Assessment
• Validation Plan
• Vendor Assessment
• Supplier Agreement – SLA
• FS-DS or SRS
• Risk Assessment, using risk-based approach for CSV
• Installation Qualification – Protocol and report
• Operational Qualification Protocol and Report
• Important SOPS
• Traceability requirement matrix
• Summary Report
• System release Certificate
• Maintenance Qualification- Periodic review, Change Control,
Incidence Management and Revalidation - Addendum
• System retirement
• How validation helps to improve your business
8. CASE STUDIES
• This will be a group activity.
• What to do after Good Validation to maintain system in a Validated
state.
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