Certificate in Computer System Validation
Computer validation is more than a compliance requirement. It is not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business.
computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale.
- Module 1. Industry 4.0 (Industrial Revolution)
- Module 2. Computer System Validation (CSV) – An Overview, Regulatory requirements and documentation
- Module 3. Software Development Life Cycle (SDLC) Overview: Waterfall, V-Model, Agile Methodology, DevOps etc.
- Module 4. High Level Risk Assessment (GxP Assessment, Software Categorization as per GAMP 5, ERES Assessment)
- Module 5. GAMP 5 Guideline Overview
- Module 6: Software Validation & Infrastructure Qualification
- Module 7:Supplier (Vendor) Assessment
- Module 8: Validation Plan, Validation Report, Test Plan & Test
Summary Report) - Module 9: Specification Overviews URS, FS, DS, CS
- Module 10:Quality Risk management (FMEA, FMECA other tools)
- Module 11: STLC – Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing)
- Module 12: Defect Management
- Module 13: Periodic Review of Computerized System
- Module 14: System Retirement
- Module 15. Data Migration
- Module 16. Back-up Stratgy – Hot Back-up, Cold Back-up, Archival & Retrieval of Data
- Module 17. Quality Management System : Change Management, Deviation, Incident, Risk Management, Quality manual and Policy.
- Module 18. Business Continuity Management (DRP, BCP, CarbonRecovery Plan)
- Module 19. Data Integrity ALCOA++
Advance Topics :-
- Module 20. Computer Software Assurance (CSA, A New CSV Approach).
- Module 21. Cloud Computing (SaaS, PaaS, IaaS)
- Module 22. Excel Sheet Validation.
- Module 23. Agile Methodology (Scrum Agile) with JIRA Software.
- Module 24. Penetration Testing (Threat Modeling, SAST & DAST).
- Module 25. Medical Device Classification
Tools To be Used & Learn :-
- Two Test Management Tools (HPALM plus One more)
- Two Task Management Tools (JIRA plus One more)
- One Document Management Tools
Following Live Projects will be teach to candidates
- Data Acquisition System (DAS)
- Chromatographic Data System (CDS)
- Packing US-Serialization System
Eligibility
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes in Computer System Validation Training
What you will get with Course
- Hands-on experience on JIRA Software for handing Agile methodology.
- Free Membership for lifetime to avail chat with our lecturer and other members of the same group
- 70,000 INR worth material free access at any time with membership for lifetime.
- interview based question and answer free access.
- Interview Preparation and Mock Interview Session.
- Communication skills and personality development sessions
- Placement Assistance
- Two batches can be Join with same fees
- One Year access for Class Recordings will be available on site to recall and create your own notes
- Certificate with 2D Code and URL for authentication.
Program Duration
The candidate is expected to complete the course in 2 months.
Registration
The registration will be carried out by contacting on Skillbee Solution. How to Apply
Program 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 program modules for continuous evaluation and guidance.
Interactive or online live sessions on all key areas of the program giving all flexibility to the participants.
Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.
All the efforts are made by faculty members to make the entire programme modules easily understandable.
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 program modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
All learning and training delivery initiatives shall be conducted in English.
Certification and Membership Fees
Contact on +91-8103635949 or +91-9691633901 or Info@Skillbee.co.in for details of fees structure
Assessment & Certification
All the participants are expected to appear for online assessment. After successfully qualifying the examination Computer System Validation Course Online, the participants will be certified by SkillBee Solution. Enrol in our e-Learn Computer System Validation training course in Pharma Industry, suitable for both beginners and professionals, with training available in Bangalore, Hyderabad, and the UK.
To start your Computerized System Validation journey in Hyderabad, UK and USA . Apply Now
Placement Assistance & Corporate Relations
The Institute has partnered with many organizations for providing with placement assistance and CSV Training Course in USA, UK, BANGLORE AND HYDERABAD and CSV Validation in Pharma to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. Education Center, Educational Consultant, Training Center,.