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Computer System Validation Training @ Gratisol Labs
An Upgrading Career For Experience Pharma Professionals.
Gratisol Labs Providing Pharmaceutical Computer System Validation For Experience Pharma Professionals. The course provides compliance with GMP requirements and specifically designed for professionals. By using a risk-based approach and in-depth understanding of various CSV methodologies including GAMP5 guidelines, Validations, Annex 11 and the CFR Part 11.
Computer system validation is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record.
Computer System Validation Modules:
• MODULE 1: FDA Regulatory Module.
• MODULE 2: Development of Validation Documents.
• MODULE 3: Documenting CSV QUALITY EVENTS.
Computer system validation deliverables
• Validation plan
• System risk assessment report
• User requirements specification
• System configuration specification
• Test plan
• Installation Qualification (IQ) testing and results
• Operation Qualification (OQ) testing and results
• Performance Qualification (PQ) testing and results
• Optional) Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
• Validation traceability matrix
• Quality assurance review
• Validation summary report
• Review of Standard Operating Procedures (SOPs)
• Technical support
Eligibility:
• Bachelor’s degree in a Life Sciences or Information Technology (IT) discipline or equivalent experience preferred.
• Minimum of two (2) years of relevant experience in Pharmaceutical Indsustry or quality required.
• GxP hardware and/or software experience preferred.
• Knowledge of 21 CFR Part 11 / Annex 11 regulations preferred.
• Knowledge of cGMP and validation regulations and requirements.
• Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements preferred.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
Venue:
Gratisol Labs,
KVR Enclave, 2nd Floor,
207, Ameerpet, Hyderabad .
Land Mark: Gurudwara
Contact - 9705790302 / 8885198390
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