Objectives of the Webinar
Introduce the participants the data integrity controls based on Recommendation for Key Management, Part 1: General (SP 800-57 Part 1 ).
Understand the importance of CSV and data integrity when using a cloud-based infrastructure.
About Orlando Lopez
Orlando is a seasoned professional with global pharmaceutical and medical devices computer systems compliance experience for companies such as J&J, Allergan, Lilly, Novartis, Pfizer, and Catalent.
Recently published a book about best practices in e-records integrity, www.routledge.com/Data-Integr....
Possesses e-compliance experience within system quality and compliance of GxP regulations/guidelines (21 CFR Parts 211.68 and 11, EU Annex 11, MHRA, PIC/S, and data integrity). Detailed knowledge of the SLC, software and e-records QA, and infrastructure qualification. Experience with risk management practices. Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), NIST, and ASTM (E2500).
27 авг 2020
