Workshop Overview
Emerging markets in Asia are increasingly seeking contract pharmaceutical manufacturing opportunities
in Europe and the US. Consequently, regulatory agencies from these countries such as the USFDA, MHRA,
EU, and Anvisa are implementing frequent and stringent audits of these contract manufacturing
companies. A review of recent warning letters indicates that 1/3rd of them have been cited for improper
validation and lack of data integrity practices and procedures. By attending this 3-day training on
Computerized Systems Validation (CSV) and Data Integrity (DI), equip yourself to successfully defend your
company during regulatory audits. Hear directly from a US-based expert who pioneered the
implementation of CFR 21 Part 11 and has successfully implemented and defended the largest
computerized manufacturing system in the world. His extensive implementation experience enables him
to make his workshop very interactive where attendees discuss implementation challenges, they face at
their workplace.
This workshop is designed for Life Science industry personnel with 2 to 20 years plus. Topics include
validation’s predicate rules, System and Validation Lifecycle, writing good requirements documents with
examples, ideal content of a CSV and CSA SOP, CSV and DI deliverables that auditors expect, new
validation guidance known as CSA, Validation and DI Maturity Model, Data governance and Data
management, Data integrity’s 5P model etc.
The trainer will interactively address your specific questions so as to empower you to
develop and execute a validation approach for a successful defence during regulatory
agency audits.