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:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501066LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
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