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Major CGMP Issues - US FDA Concerns in 2022
Presented By ComplianceOnline
Tuesday, May 31st at 10:00am PST
Online sale ends: 05/31/22 at 9:30am PST
online event
6201 America Center Drive Suite 240 San Jose, CA 95002, USA
San Jose, CA 95002
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Description

A review of recent US FDA Inspectional Observations / FDA Form 483 Observations, as well as FDA statements and actions, indicate the major areas of regulatory concern. The past is no indicator of present or future concerns. The Agency uses publicized high-profile cases to drive compliance in the regulated industries. Certain CGMP areas, e.g., CAPA, are receiving increased scrutiny. "Risk-based" (patient risk) is another. Failure to correct problems leads to Warning Letters or more severe regulatory actions. Requirement for "better science" must be evident in compliance. "Business as usual" is never acceptable, but do some of a company’s documents reflect that outdated thinking. Also changes from the EU, MDD to MDR, ISO 13485:2016 ... confusion over what is "Risk". Don't be caught off guard by these major shifts in emphasis. Refine internal audits and get your company prepared to address the FDA's most recent requirements both in the US and outside.

This tougher emphasis also affects clinical trial expectations, product submissions and company response requirements. This change has a major impact on individual compliance objectives, efforts and measurements of success. The definition of "Risk" in systems and documentation can make the difference in a "Pass" or "Fail" regulatory inspection.


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10:00am to 11:30am
Doors open at 10:00am

General Admission: $249.00

online event<br> 6201 America Center Drive Suite 240 San Jose, CA 95002, USA<br> San Jose, 95002

+1-888-717-2436

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