Data integrity is a fundamental element of a pharmaceutical quality system and has a direct impact on product-related decisions and traceability. Accountabilities for ensuring data integrity run throughout an organization, from product development, through manufacture and testing, to product distribution and safety monitoring.
The impact of data integrity issues can be significant on a regulated company. There has been increased regulatory focus on all aspects of data integrity, including publication of specific Regulatory Guidance on the topic, and increased number of citations in the area.
This is the time, for life science companies, to conduct Data Integrity Assessment on their processes and computerised systems to evaluate risks and identify proper mitigation actions.
Who should attend?
The workshop is suitable for people working in the Life science sector that are responsible of ensuring or assessing the compliance of processes and computerised systems to requirements and expectations relating to the controland management of GxP data.
Participants should have a good knowledge of GxP regulations in particular of GDocP and strengthen basic knowledge of computer validation regulations and guidance (e.g. GAMP5).
The workshop provides a general introduction of data integrity principles taken from the different guidance to provide a clear picture of the main concepts.
The workshop methodology focus is on practical case studies analysis, in particular on computerized systems.
The attendees are continuously involved in the identification of data integrity gaps, risks evaluation and definition of mitigation actions.
Type of Training
At the end of the training, you will be able to:
• Understand the data integrity principles
• Identify data integrity impact on processes
• Increase awareness on data integrity risks
• Know how to incorporate the aspects of data integrity into the design and qualification of new computer system
Stefano Piccoli is the Founder of Qstep srl, a consultancy company, working in the Life Science industry, specialized in Data Integrity, Computer System Validation and IT Compliance
services for the GxP environment. Stefano has an extensive experience spanning more than 15 years in the regulated (GxP) pharmaceutical environment within the following
areas: Computer System Validation (CSV), IT QA/Compliance, IT GRC (governance, risk & compliance), Data Integrity, Data Privacy and regulatory audits.