AN ISO 9001:2015 CERTIFIED
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Certificate in Computer System Validation
Computer validation is more than a compliance requirement. It 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 to examine their 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. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.
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Module 1: Software Validation & Infrastructure Qualification
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Module 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation
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Module 3: High Level Risk Assessment (GxP Assessment, Software Categorization as per GAMP 5, ERES Assessment)
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Module 4: GAMP 5 and documentation (URS, FS, DS, CS, Source Code Review Report, Validation Plan, Validation Report, Test Plan & Test Summary Report)
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Module 5: Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing)
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Module 6: Penetration Testing (Threat Modeling, SAST & DAST)
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Module 7: Excel Sheet Validation
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Module 8: Cloud Computing (SaaS, PaaS, IaaS)
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Module 9: Software Development Life Cycle (SDLC) : Waterfall, V-Model, Agile Methodology, DevOps etc.
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Module 10: Back-up and Restore, Archival & Retrieval of Data
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Module 11: Business Continuity Management
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Module 12: System Retirement & Data Migration
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Module 13: Quality Management System and Quality Risk Management
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Module 14: Computer Software Assurance (CSA Approach), A New way of working for CSV
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Following Live Projects will be teach to candidates
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Data Acquisition System (DAS)
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Chromatographic Data System (CDS)
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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.
Upon Successful completion of Course our team will provide Following
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Resume Preparation
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Interview Preparation and Mock Interview Session.
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Communication skills and personality development sessions
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Placement Assistance
Program Duration
The candidate is expected to complete the course in 2 months.
Registration
The registration will be carried out by contacting on Company Connect Consultancy. 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.
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Assignments for all the programme modules for continuous evaluation and guidance.
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Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
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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.
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All the efforts are made by faculty members to make the entire programme modules easily understandable.
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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.
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At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
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All learning and training delivery initiatives shall be conducted in English.
Certification and Membership Fees
Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure
Assessment & Certification
All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified by Company Connect. Enroll 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, Apply Now
Placement Assistance & Corporate Relations
The Institute has partnered with many organizations for providing with placement assistance to in 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.