COMPUTER SYSTEM VALIDATION TRAINING

(FOR PHARMA STUDENTS AND FRESHERS)

PROGRAMME DETAILS

Training Dates:  25 FEB 2021 to 27 FEB 2021

Batch Timings:  03:00 PM to 05:00 PM IST

Programme Duration:  06 Hours (Daily 2 hours)

PROGRAMME FEES

Rs 6,000 + (GST 18% extra) = Rs 7,080/- (Including GST)

Note: The student has to provide Institution identity card to grab this offer.

 

Days
Hours
Minutes
Seconds

TRAINER'S PROFILE :
MR. KALPESHKUMAR R. VAGHELA

  • Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems and Founder partner of KVS Technologies.
  • He has 34 years’ experience as Automation and Software Validation Specialist, Expert Trainer on CSV- Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9 Risk assessment- Proactive CSV Approach-Annex11- GDPR- Remediation.
  • Since last two decades Mr. Kalpeshkumar Vaghela has been helping Indian and International Pharma – Process Companies achieve compliance by training and motivating professionals for QbD, and Right First Time Approach.
  • He has supported client for many USFDA, MHRA, ANVISA, MCC, TGA Audits as a CSV- GxP consultant.
  • He also helps in GAP Assessment, Data Integrity Audit and Remediation program.

PROGRAMME DELIVERABLES

  • A comprehensive study material for all the modules in soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

Topics

Day 1

Module 1: BASIC OF VALIDATION AND QSIT COMBINED

  • Why the need for Validation came in to picture?
  • Benefits of Validation
  • Validation Definition
  • Brief Details of Predicate Rules CFR211/210
  • QSIT
  • Marketing is all P and Compliance is also all P

Module 2: 21 CFR PART 11

 

  • Main points
  • Legacy System
  • Open System
  • Close System
  • 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
  • Electronic Records
  • Hybrid Systems

Day 2

Module 3: GAMP5

  • Basics of GAMP5
  • GAMP5 Driver
  • Patient Safety- product Quality-Data Integrity
  • CQA-CPP
  • QbD Systems
  • SDLC Life Cycle
  • Vendor Qualification, SLA
  • Conclusion

Day 3

Module 4: CSV DELIVERABLES

  • 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- Change Control, CAPA, Incidence and Some SOP
  • 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 busines

***Followed by quiz and question answer session***

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