Federal Food & Drug and Cosmetic Act Changes in 2019

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Duration : 60 min


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The industries governed by the Food and Drug Administration (FDA) are changing fast. Over the last few years, FDA has felt the impact of and the need to respond to these changes.  Innovation, emerging markets and growing consumer expectations around reliability, security and transparency are prompting regulatory action from the FDA. Just as health care, medicine, robotics, and information technology are rapidly evolving and intersecting, FDA has been forced to pick up the pace as the lead regulatory authority over therapeutic products, diagnostics, and medical devices.  As a result, policy changes and new guidance documents are being issued more quickly then ever before. 

Why should you attend?

Regulatory expectations and requirements are changing to keep up with modern innovation at an ever-increasing speed.  The consequence of non-compliance can range in severity for an organization.  All of which are highly undesirable as they have such a negative impact on the firm, the personnel employed there, and potentially the patients.  These consequences include such actions as 483 observations, Warning Letters, product seizure, and substantial fines.  It is essential for industry professional to stay up to date with current regulatory expectations and requirements in order to maintain compliant quality systems. 
This presentation covers key FDA initiatives in the pharmaceutical and medical device industry that compliance professionals should be aware of, including continuous manufacturing, inspection scheduling, cGMP compliance, and more.

Covered in the Session:

Topic 1:  Changes in the FD&C Act impacting Pharmaceutical Products
·  21st Century Cures Act
·  Easing and Accelerating the Pathway to Market
·  Drug Competition Action Plan and Biosimilars Action Plan
·  The Shift in Quality, Inspections, and Enforcement

Topic 2:  Changes in the FD&C Act impacting Medical Devices

·  510(k) Modernization & De Novo Proposed
·  Medical Device Single Audit Program (MDSAP)
·  Digital Health
·  CMMI Case for Quality

Topic 3:  Changes in the FD&C Act impacting Food

·  FSMA Implementation, Education, and Soft Enforcement

Who will benefit?

·  Regulatory Affairs
·  Quality Assurance
·  Marketing managers
·  Product Manager
·  Labeling managers
·  Professionals in Pharmaceuticals, Biotech, Medical Device, and anyone involved with FDA

*You may ask your Question directly to our expert during the Q&A session.

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