Overview of Computer Systems Validation (CSV)

Computer Systems Validation (CSV) is a critical process that ensures computer-based systems generate information or data that meet specific requirements. This process is vital in highly regulated environments, such as pharmaceutical and medical device manufacturing, where public health and safety are directly impacted. Beyond regulatory compliance, CSV enhances understanding of systems during implementation and ensures a structured approach to project execution. It offers businesses the opportunity to examine and optimize their computer systems, ultimately improving quality while saving time and costs. Experts in CSV play a key role in realizing these benefits.

Who Should Enroll

This course is beneficial for anyone involved in FDA audits and CSV on both domestic and international levels. It is particularly relevant for professionals in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, and Quality Control, as well as those who interact with vendors and regulatory agencies.

Importance of Computer Systems Validation

In regulated industries like pharmaceuticals, compliance procedures are essential to ensure products are safe for distribution. CSV is a vital component of the Quality Management System in pharmaceutical manufacturing, delivering key benefits such as:

– Accuracy: Ensures test outcomes align with expected results.

– Security: Clarifies when system entries have been modified.

– Reliability: Confirms that system outputs remain dependable throughout their lifecycle.

– Consistency: Guarantees uniform system output across its lifecycle.

– Optimization: Facilitates the enhancement of computer systems for efficient manufacturing.

Course Content 

Participants will receive extensive training in CSV, covering essential topics such as:

– Common terms and definitions of CSV

– Elements of the System Development Life Cycle (SDLC)

– Good Automated Manufacturing Practices (GAMP)

– Data integrity concerns in GxP contexts

– FDA regulations on computer systems

– Understanding compliance, risk, and regulatory impacts of computer systems

– Achieving and maintaining 21 CFR Part 11 compliance

– ERP Systems Validation training

Modules Covered

Basic Certification Program

1. Quality, Quality Assurance, and Quality Control in Pharma and Healthcare
2. Qualification and Validation
3. Introduction to CSV
4. Software Development Life Cycle (SDLC)
5. Regulatory Requirements for Software Validation – 21 CFR Part 11
6. Risk-Based Approach to Software Quality and Validation
7. GAMP 5 Guidelines & Software Categories
8. Implementation in Life Science Verticals
9. Quality Certifications, Government Regulations, ICH Guidelines, and ISO 9000
10. GDP, GCP, GMP Guidelines

Advanced Certification Program 

Includes all Basic modules plus:

1. Software Quality Audit
2. FDA Inspections & Warning Letters (Case Study Approach)
3. Importance and Principles of Data Integrity
4. Developing a Data Integrity Plan and Guidance Document

Eligibility Criteria 

Candidates should have one of the following qualifications:

– Life Sciences degrees (B. Pharmacy, M. Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.)

– Engineering degrees (B.Tech/M.Tech in Biotechnology/Bioinformatics/Pharmaceutical Science)

– Computer Science degrees (B.Sc./M.Sc. in Computer Science/Electronics/IT)

– Professionals from IT, Pharmaceutical Organizations, or CROs.

Selection Procedure

To maintain high academic standards, candidates will undergo:

– Personal interviews

– Screening and selection process

Post-Training Support

Upon successful course completion, participants will receive assistance in:

– Resume preparation

– Interview preparation (including mock interviews)

– Communication skills and personality development

– Placement assistance

Placement Opportunities

The Institute collaborates with numerous pharmaceutical and healthcare organizations for placement support. A dedicated placement cell, staffed by experienced HR professionals, actively promotes participant employability and engages with hiring managers.

Career Prospects 

Professionals in CSV can explore roles such as validation specialists, validation engineers, QA consultants, and IT validation analysts. The field has experienced significant growth since the 1990s, driven by evolving technology and increasing regulatory demands.

Certification

Participants will receive a certificate upon completing self-assessment assignments and live projects, awarded by Pharma Connections.

For more information, please contact Pharma Connections at info@pharmaconnections.in