David Abraham, Quality Resource Solutions Associates
The issue surrounding data integrity has now been with us for several years since regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO) and the European Medicines Agency (EMA) started to raise concerns to the industry. The application of data integrity is integral to Good Distribution Practice (GDP) and as complexities of pharmaceutical distribution continue to present new challenges throughout the supply chain to ensure medicinal products are not compromised. As regulators intensify their focus in data integrity it is important that managers, supervisors and Responsible Persons understand how data generation and flow are vital to ensure robustness within the supply chain and integral to GDP processes and systems.
The webinar is aimed at all personnel involved at all levels within the following industries: Pharmaceutical manufacturers (e.g. logistics and QA), drug wholesalers, logistics companies, external warehouses, extended service providers offering services in support of the distribution of medicinal products.
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This webinar aims to give participants a compact overview on how data integrity interacts with GDP as well as understanding expectations of current guidance. The following topics will be covered:
- Understanding data integrity
- The differences between data and data integrity
- Guidance and industry Standards
- The principles of data integrity
- Data flow in GDP
- Integrating data integrity governance on GDP