Module 1: Computerized System validation in Lifescience Sector Why CSV? Regulatory guidelines governing CSV GAMP guidance for validation of Computerized Systems Which computerized systems need to be validated? ERPs PCS LCS Infrastructure HVAC How to validate? Documentation for CSV Maintaining system compliance 21 CFR Part 11 Compliance ix. Warning Letters and Form 483 with relevance to CSV Module 2: Regulatory Affairs and Submissions Various Regulations and requirements of Countries Types of key regulatory submissions Regulations in India Regulatory Submissions to DCGI v. Schedule M and its implications in India Module 3: Intellectual Property Rights Introduction to IPR The regulations and treaties governing IPR all over the world Indian Patent Act 1970 and its amendments IPR in Pharmaceuticals Patent search, drafting of patent claims and specifications Indian Patent scenario Case Studies