Preparing for an FDA inspection – what you need to know

This Expert Insights webinar presented by MMS Holdings will provide an informational overview on the intersection of inspection readiness, quality systems, and regulatory submissions. Aspects of Quality by Design and Quality System Management provide a framework for building robust and compliant dossiers for successful regulatory submissions, as well strategies to reinforce compliance within your program to ease the regulatory inspection process and improve the outcome. Understanding the regulations is only half the battle, and defining a strategy for continuous compliance will allow for a successful drug or biologics approval. During this webinar, MMS will discuss aspects of preparing for inspections and regulatory submissions, including: -Providing an introduction to types of inspections including NDA and BLA pre-approval inspections -The strategy – a three-pronged approach and best practices to ensure compliance -Quality Assurance and Risk Assessment tools to aid in Inspection Readiness -Knowing what the inspector knows – Using the compliance program manual as a guide for preparations -Value of coordinated planning between QA and Regulatory Affairs including clear responsibilities and timelines Presenters: Jennifer Perrin, Senior Quality and Compliance Specialist (Ohio, USA) Simon Powell, Senior Quality and Compliance Specialist (United Kingdom) This presentation was originally given on October 22, 2020.