Companies manufacturing pharmaceutical products for the US market must understand not only the applicable FDA regulations, but also how the Agency interprets and assesses compliance during inspections.<\/p>\n
This course provides participants with a practical understanding of the FDA regulatory framework, US current Good Manufacturing Practices (cGMPs), and the way FDA investigators approach pharmaceutical manufacturing inspections. Attention is given to FDA Pre-Approval Inspections (PAIs), including their objectives, areas of focus, inspection management practices, employee interaction with investigators, and the potential consequences of non-compliance.<\/p>\n
The course combines regulatory knowledge with practical inspection-readiness concepts to help participants understand what FDA inspectors expect and how organisations should prepare for and manage an FDA inspection.<\/p>\n","protected":false},"excerpt":{"rendered":"
Advanced FDA Inspections and US cGMP Compliance Practical Inspection Readiness and Pre-Approval Inspection Management Companies manufacturing pharmaceutical products for the US market must understand not only the applicable FDA regulations, but also how the Agency interprets and assesses compliance during inspections. This course provides participants with a practical understanding of the FDA regulatory framework, US … Continued<\/a><\/p>\n","protected":false},"featured_media":22236,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-22230","product","type-product","status-publish","has-post-thumbnail","course_topics-gmp","course_types-corso-online","productgroup-advanced-fda-inspections-and-us-cgmp-compliance-practical-inspection-readiness-and-pre-approval-inspection-management","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product\/22230","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/22236"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=22230"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=22230"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=22230"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=22230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}