There are several different definitions of cloud computing, but all of them agree on how to provide services to users of the network. Cloud computing is an Internet-based development and use of computer technology. It refers to the use of computing resources; hardware and software, available on demand as a service over the Internet. It offers a range of services for users of the network, which include applications, storage, and various operations and remote printing, etc.The objective of this presentation is to go over those elements in data integrity impacting cloud related services.
About the Presenter
• Orlando is a seasoned professional with global pharmaceutical and medical devices computer systems compliance experience for companies such as J&J, Allergan, Lilly, Novartis, and Pfizer.
• SME in the interpretation and application of e-compliance regulations and standards.
• Practical experience in a role that includes implement and maintain the Data Integrity (DI) Quality Management System, communicate pertinent DI information, support DI training, and promote a healthy DI culture.
• A thorough and demonstrated knowledge in GxP regulations/guidelines with a high emphasis in EU Annex 11, MHRA, 211.68, 820.70(i) and related regulatory guidance
• 15 years of work experience in manufacturing operations within the FDA regulated pharma industry, which includes working as part of global teams
• Direct participation in regulatory inspections, response activities, remedial action plans, and consent decree remediation related verifications