ADVANCED PHARMACEUTICAL COMPUTER SYSTEM CERTIFICATION PROGRAM - CSV CERTIFICATION TRAINING

About CSV Course:

Computer System Validation course at Clin Infotech has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This CSV course introduces participants to Entire regulatory Guidelines and their Requirement for computerized systems in the pharmaceutical industry and explores internationally recognized methods of meeting those requirements With the full tried, tested Methods and provides a pragmatic and effective framework and meet current regulatory requirements. The CSV course aim to cover detailed and highly technical aspects of software and hardware internal engineering and also gives the full fledge 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 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.

CSV Certification 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.

Over the past decades, the life science industry has progressively introduced computer systems to support clinical trials, manufacturing, control, and logistics processes. As a consequence, these computer systems became critical elements from the point of view of current GxP regulations on electronic data integrity and therefore, the regulatory authorities have significantly increased their vigilance on the adequate control over electronic data systems.

What is Computer System Validation?

Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work.

SCOPE OF COMPUTER SYSTEMS VALIDATION?

As computer systems are increasingly integrated into many of the most important business processes, they help to reduce or eliminate the risks inherent in manual processes traditionally performed by qualified personnel.

Computer systems with GxP impact are becoming of particular importance today due to technological advances in process automation and data management. The increasing acceptance and use of these technologies in both administrative, industrial, and productive processes highlight their importance.

What can 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 – 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

CSV COURSE SYLLABUS:

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Eligibility:

Any Life Science degrees:

• B. Pharmacy, M. Pharmacy
• Bachelor’s, Master’s in Life-Sciences (Microbiology, Biochemistry, Biotechnology or related fields)
• B.Tech (Biotechnology/Bioinformatics / Pharmaceutical Science)
• M.Tech (Biotechnology)
• All Experience professionals in: Drug Manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry

Why Clin Infotech for CSV Course

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Placement Assistance @ Clin Infotech

Clin Infotech has partnered with many Pharmaceutical & Healthcare organizations for providing placement assistance to its participants. Clin Infotech has a dedicated placement cell and team of Talent Acquisition experts which maintains high references with business and industry encouraging the placement of the Computer System Validation Training participants.

Future Career Prospects of Computer System Validation:

Companies, particularly the Pharmaceutical industries, must validate their information technologies to ensure they meet the intended business standards. Computer System Validation is a vast area which every Pharma Manufacturing Regulatory industry requires, which leads to growing job opportunities for Pharma Experience Professionals.

Thus, Pharmaceutical Computer System Validation trained professionals have a great demand in the IT Industry. At Clin Infotech, we ensure the participant learns basic to advanced Computer System Validation, involving activities primarily around:

• Generating requirements and specification documents
• Testing systems against specifications
• Documenting test results during the CSV Training Course

As we maintain high quality standards, Clin Infotech is the best Computer System Validation Training Institute. We provide both online CSV course and offline CSV course.

Certification:

Clin Infotech will provide a CSV Certificate for the CSV Certification Course upon successful completion of self-assessment assignments & live projects. The CSV Certificate will be awarded after the completion of the training.

Placement Opportunities:

Clin Infotech is a pioneer in providing Computer System Validation training and placement program. We are India’s first ISO 9001:2015 certified institute with placement cells operated in Hyderabad, Bangalore, Pune, and Mumbai.

Our well-integrated training cum internship programs are integrated with real-time CSV project-based learning and ensure our outstanding placement record of 100% genuine placement assistance and lateral placements.

Our Placement Companies:

For more information, please contact Clin Infotech at careers@clininfotech.com