(Un texte en français suit)
In this topic our speaker deep dives into numerous European and US regulations and guidance documents taking you on a journey to mine the true definition of Data in the GxP concept and revealing the real scope of data integrity in the pharmaceutical process.
Participants will be first introduced to the principals of Data Integrity ALCOA + and their roots in different regulatory and Pharma industry guidance documents.
They will then be introduced to a bottom-up data integrity model to overcome the visualization and communication challenges of such a complex subject in the most efficient way through their organizations.
About the speaker: Kia Kahhali, B. eng. has over 25 years of experience, in equipment and system validation with proven records in the pharmaceutical industries, Kia is a reliable expert and an insightful leader in his domain.
He has built a unique profile by tying his engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
Kia has a proven record of conception and realization of AIQ life cycle processes as well as Data governance programs, plus assessment and remediation of the Data integrity gaps and CSV.
He founded APS Compliance Consultants Inc in 2018 which has since been highly solicited by North American pharmaceutical industries as a reliable consulting firm. APS Compliance Consultants Inc (also known as Access Pharma Solutions) is a private firm of experts assisting the Pharmaceutical and Food industries.
Kia believes in giving back to the community and shares his experience with the industry on different occasions and has been a featured speaker and a panellist in the Annual GMP Update held by International Pharmaceutical Academy in 2020 and 2021.