Data integrity is a fundamental element of pharmaceutical quality and regulatory compliance. Regulators expect organisations to demonstrate that GxP data are complete, consistent, accurate, attributable and reliable throughout the entire data lifecycle. Failure to meet these expectations can compromise confidence in the data used to support product quality and may result in significant regulatory findings.<\/p>\n
This practical workshop provides participants with a clear understanding of Data Integrity principles and how they apply to both paper and electronic records. The course explores the ALCOA+ principles in detail and translates them into practical expectations for everyday activities, including documentation, electronic systems, audit trails, data transcription, record review, calculations and critical process data.<\/p>\n
Emphasis is placed on identifying Data Integrity vulnerabilities, distinguishing accidental failures from intentional falsification, assessing the criticality and impact of Data Integrity deficiencies, and designing processes and controls that reduce opportunities for errors and non-compliance.<\/p>\n
Through real regulatory observations and practical workshops, participants will apply Data Integrity concepts to realistic pharmaceutical scenarios and identify appropriate corrective and preventive actions.<\/p>\n","protected":false},"excerpt":{"rendered":"
Data Integrity and Data Governance Data integrity is a fundamental element of pharmaceutical quality and regulatory compliance. Regulators expect organisations to demonstrate that GxP data are complete, consistent, accurate, attributable and reliable throughout the entire data lifecycle. Failure to meet these expectations can compromise confidence in the data used to support product quality and may … Continued<\/a><\/p>\n","protected":false},"featured_media":22504,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-22500","product","type-product","status-publish","has-post-thumbnail","course_topics-gmp","course_types-corso-online","productgroup-data-integrity-and-data-governance","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product\/22500","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media\/22504"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media?parent=22500"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_brand?post=22500"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_cat?post=22500"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_tag?post=22500"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}