Training & seminars
Computer Systems for Regulated Environments/Data Integrity (25 – 27 June 2018) – 3 day Course
22 December 2017
Aim: Computer Systems are an established and integral part of management in modern Life Science organisations. All users must ensure that their systems and software have been developed to best engineering practices in a quality assured and secure manner to comply with Regulatory Requirements and to be fit for Business Use.
Data Integrity has become widely discussed as a global concern for the pharmaceutical industry. This section provides an introduction to develop a broad understanding of the scope of Data Integrity and how key principles may be applied in order to provide strategic elements necessary to ensure reliability and integrity of information and data throughout all aspects of a product’s lifecycle.
Day 1 AM ► Understand how computer systems are regulated in the local and global regulatory environment AM ► Understanding the controls necessary to demonstrate data integrity
PM ► Computer Systems Selection and Vendor Qualification
Day 2 AM ► Developing a risk-based approach to CSV With AM ► Best practices for validation test execution, documentation and error handling
PM ► Understanding how the CSV process fits into the company’s Software Life Cycle (SLC), understand the types of, and elements of System Development Life Cycles (SDLC) and the use of GAMP 5
Day 3 AM ► Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations.
PM ► Hands-on practice creating key validation deliverables, including requirements, test plan, test scripts and test summary
PM ► Data Integrity: