Bangladesh program
Good practice guidance on – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5) During COVID 19 Outbreak In ever changing business set-up, it is a challenge to develop an appropriate Validation Program that meets business, technology and compliance needs of the industry specifically when world is going through pandemic for COVID 19 virus outbreak. It takes a lot more than just a single technology to make computer systems comply with GxP/21 CFR Part 11 requirements. It involves, good quality processes and controls to have the systems comply with regulations and hold them in a validated state. EIC is organizing a webinar that focus on some of the challenges faced by industry in conceptualizing and implementing a validation program. This webinar explores with the audience the challenges in general and provides an advanced approach to Computer System Validation and compliance to 21 CFR Part 11. • Overview on CSV and 21 CFR Part 11 • Ensuring compliance with new normal • Risk Management and GAMP5 Risk Based approach • Keeping the computer system in validated state – Change Management • General challenges in building an effective validation program • Business returns for validation program • Managing Validation Projects during pandemic. • Q&A Session Who should Attend? This CSV webinar will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. • IT Managers, • Project Managers, • Compliance Managers, • Regulatory Managers, • QA, • Drug Safety.
