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08:30 AM TO 05:30 PM
Trainer, speaker, writer and CSV consultant – that is the amalgam which describes Dr Neelam Tripathi. She has explored Pharma and Healthcare world with several MNCs including TCS. Having more than 17 years of experience, she is an expert in CSV, 21 CFR Part 11, compliance and quality. She has trained teams for CSV, GDP, GCP, HIPAA and Healthcare.
Worked primarily in the field of Software Quality Assurance (SQA), Computer System Validation (CSV). Expert in requirement gathering (URS and FRS), creating validation master plan (VMP) and other deliverables (RS, DS, RTM, Test Cases, VSR).Risk and compliance assessment. Test cases and defect management
She ensured following for training management: Training need analysis , Creation of content, modules, and training plan , Ensuring 100% compliance on training schedules , Feedback analysis , Selection and co-ordination with faculty
Ramana Gadicherla is strategic leader with specializing in delivering large scale projects with Quality and Compliance. He is having extensive experience in FDA (GxP, 21 CFR Part 11), PIC/S, EUDRALEX and other regulations. He also having extensive experience in Consent Decree Remediation's. He is leader in implementing large scale programs like SAP, LIMS, Qualification of Data centers Experience in setting up and managing IT Regulatory CoE (Validation and Quality). He is specialist in managing quality, compliance, risk and security for very large engagements spread across the globe.
His specialties include Program Delivery Management for Global delivery. Compliance and Quality Management. Life Sciences IT Compliance (FDA (21 CFR Part 11), IMDA, PICS, EUDRALEX). Building and Handling Validation/Quality CoE Internal / external and Vendor Audits. Gap Assessments for Consent Decree / 483 / Import Alert Remediation's. Stand Alone Systems Validation along with PLC Spreadsheet Validations. Large scale data center qualification Management of SOP, policies. Managed team size over 120 people across geographies. Trained over 500 members in Quality IT, testing methodologies Validation techniques, CSV, Quality standards, GxP.
Head Computer System Validation
Deputy General Manager
Head-Process Excellence & Lean Six Sigma Quality
Ananda Rao C
General Manager - QA, CSV and MR