Validation

ADVANCED CERTIFIED PROGRAM IN COMPUTER SYSTEM VALIDATION

Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing.  

This course will provide extensive training in Computer system validation.  The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. It’s crucial that any process within these manufacturing industries reliably behaves in a consistent way.

Pharmaceutical manufacturing and medical device manufacturing industries are increasingly relying on computer systems to operate a range of manufacturing processes, so it’s more important than ever that these systems can be relied upon to follow a predetermined specification.

Why Do We Need Computer Systems Validation?

Regulated industries, such as pharmaceutical manufacturing, have to adopt many compliance procedures to make sure their final product is safe for distribution or sale. CSV is one of those compliance requirements and is part of the Quality Management System within pharmaceutical manufacturing.

So what exactly does CSV deliver to these industries?

  • Accuracy – When test outcomes are routinely checked against predetermined expected results, the      accuracy of computer systems within the manufacturing process can be relied upon
  • Security – CSV processes make clear when entries to the system have been altered
  • Reliability – The process ensures that system outputs can be relied upon throughout the lifecycle
  • Consistency – it also ensures that the system output is consistent across its lifecycle
  • Optimisation – following the process also means that computer systems can be more easily optimized. Optimisation is a key feature of an effective and efficient manufacturing site.

 Following Course Content will be covered during the training:

  • Common terms and definitions of Computer Systems Validation
  • The elements of System Development Life Cycles (SDLC)
  • Good Automated Manufacturing Practices (GAMP).
  • Data integrity issues in the eyes of GxP regulators.
  • How computer systems are regulated in FDA environments
  • Ability to recognize the compliance, risk, and regulatory consequences of using computer systems
  • Achieving and Maintaining 21 CFR Part 11 Compliance
  • Training-on ERP Systems Validation.

 ELIGIBILITY:

Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)   and all professionals working with IT, Pharmaceutical Organizations & CROs.      

SELECTION PROCEDURE:

  • To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:
  • Personal Interview 
  • Screening And Selection Of Students 

OUR TEAM OF EXPERIENCED CSV SPECIALISTS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:

  • Resume Preparation 
  • Interview Preparation with real time questions and answers
  • Mock Interview Sessions
  • Communication Skills and Personality development Sessions
  • Placement Assistance

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

For more information, please contact Gratisol Labs at This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

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Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com