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Join former FDA Investigations Branch Director Ricki Chase – now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.
Compliance 360 Podcast Survival Guide is brought to you by Medtech Insight
With Medtech Insight, you can access extensive coverage of global medtech news and insight. Grasp global trends and source information on the impact of technologies like diagnostic imaging, drug delivery, 3-D printing and more.
Podcast Lineup
February 6
Handling Difficult US FDA Investigators
February 13
Getting The Most Out Of Your Inspection:
Close-Out Meetings
February 20
Building Trust With US FDA:
Can It Be Done?
February 27
How To Better Manage Your Quality Data
March 6
Medical Device 483s:
US FDA’s Top 5 Observations
March 13
Don’t Do That!
How To Respond To FDA-483s
March 20
Factors Feeding Your Inspection Cycle:
A New Paradigm
March 27
Patient Influence On US FDA’s
Enforcement Strategy
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Medtech Insight: global medical technology news & analysis
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.
Topics FDA
Medtech Insight: global medical technology news & analysis
By Marion Webb
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.
Topics Digital Health FDA
Medtech Insight: global medical technology news & analysis
RTI Surgical, a surgical implants company, hired a global spine president and an original equipment manufacturer products president; Guerbet, a maker of medical-imaging products, promoted its chief commercial officer to CEO; and more.
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