COMPUTER SYSTEM VALIDATION TRAINING
(FOR PHARMA STUDENTS AND FRESHERS)
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)
Rs 6,000 + (GST 18% extra) = Rs 7,080/- (Including GST)
Note: The student has to provide Institution identity card to grab this offer.
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.
- 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.
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
- 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
- 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
Module 3: GAMP5
- Basics of GAMP5
- GAMP5 Driver
- Patient Safety- product Quality-Data Integrity
- QbD Systems
- SDLC Life Cycle
- Vendor Qualification, SLA
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***