Inspections and Audits

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Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share critical factors you need to consider in using RWE and provide insight into the current and planned uses of RWE to support development and post-approval safety studies. View

The drug pricing and reimbursement landscape is changing dramatically. Understanding the current policies — and proposed changes — and how to apply them to product development and commercialization plans will greatly impact the success of your products. View

This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

The report covers critical elements of the product and process flow, strategies and tools a qualified person can use to manage supply chain, import, technical agreements and delegation. View

Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View

The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View

Karla Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the 2018 Compounding Priorities Plan and shows what’s behind the accelerating enforcement. View

Unless you are completely up to date with relevant cleaning and disinfection industry guidance documents, regulations and auditor findings… your current program may be in trouble. View

The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. View

Perch on the shoulder of an expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time. View

Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications. View

John Fuson — former Associate Chief Counsel for Enforcement, FDA — will review factors that increase enforcement risks and provide insights on how enforcement progresses from inspectional observations to 483s, warning letters, seizures, injunctions and possible criminal actions or jail time. View