Conference Details

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Date :

Place : United States, Baltimore

Website :

Contact Person:John Robinson

Description:

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. will be held in Baltimore,United States on date 2017-04-07

Deadline for abstracts/proposals : 5th April 2017

Organized By :Netzealous LLC

Keynote Speakers : David R. Dills, Regulatory Affairs & Compliance Consultant. David R. 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. Previously employed, with increasing responsibilities by device manufacturers and consultancies,

Conference Highlights :Agenda: Lecture 1: How a firm should prepare for an FDA inspection Lecture 2: Ways to train employees in view of the inspection Lecture 3: How to ensure that required documentation is in place Lecture 4: How to interact with the investigator-DO's and DON'T's Lecture 5: What companies should do when the inspection ends Lecture 6: How to reply to 483's and warning letters Lecture 7: Legal implications of non-compliance Lecture 8: Post inspection actions Day 2

Venue :The DoubleTree Baltimore-BWI Airport, 890 Elkridge Landing Road - Linthicum, MD 21090

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This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

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