Computer System Validation

ANSM TECHNOLOGIES

 

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.

 

  • Module 1: Software Validation & Infrastructure Qualification

  • Module 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation

  • Module 3: High Level Risk Assessment (GxP Assessment, Software Categorization as per GAMP 5, ERES Assessment)

  • Module 4: GAMP 5 and documentation (URS, FS, DS, CS, Source Code Review Report, Validation Plan, Validation Report, Test Plan & Test Summary Report)

  • Module 5: Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing)

  • Module 6: Penetration Testing (Threat Modeling, SAST & DAST)

  • Module 7: Excel Sheet Validation 

  • Module 8: Cloud Computing (SaaS, PaaS, IaaS)

  • Module 9: Software Development Life Cycle (SDLC) : Waterfall, V-Model, Agile Methodology, DevOps etc.

  • Module 10: Back-up and Restore, Archival & Retrieval of Data

  • Module 11: Business Continuity Management

  • Module 12: System Retirement & Data Migration

  • Module 13: Quality Management System and Quality Risk Management 

  • 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 

  • 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.

Upon Successful completion of Course our team will provide Following

  • Resume Preparation 

  • Interview Preparation and Mock Interview Session.

  • Communication skills and personality development sessions

  • 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 ANSM TECHNOLOGIES.

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 programme modules for continuous evaluation and guidance.

  • Interactive or online live sessions on all key areas of the programme 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 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.

Certification and Membership Fees

Contact on +91-8096510123 or ansmtechnologies@gmail.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. e-Learn Computer System Validation online training course in Pharma Industry for Beginners and Professionals are available in Bangalore, Hyderabad. 

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. 





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