Compliance4All, Online
2017-01-12
Overview: The US Food and Drug Administration has recently released information
about its new strategies as a result of the new administration.
The new commissioner recently announced a new policy for Warning
Letters and FDA-483 responses, putting manufacturers under very tight
response timelines.
Areas Covered in the seminar: The "new" FDA organization and mission Enforcement changes- increased inspection Enforcement Changes-new expectations Manufacturers responsibilities for FDA-483s Manufacturers responsibilities in Warning Letter situations Pre-market changes-Human Factors New Risk Management Guidance
Who Will Benefit: Regulatory Managers Quality Managers Product Managers Project Managers
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