How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

Date : 26th September 2018 to 27th September 2018

Place : United States, Washington

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901747SEMINAR?allconferencealerts-sep-seo

Contact Person:Event Manager

Description:

Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection.

How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection will be held in Washington,United States on date 2018-09-27

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Deadline for abstracts/proposals : 26th September 2018

Keynote Speakers : David R. Dills Global Regulatory Affairs & Compliance Consultant and President, NovaQual David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties

Conference Highlights :This seminar will offer learning on the following: How a firm should prepare for an FDA inspection Ways to train employees in view of the inspection Field Management Directives Sub-Systems for Pharmaceutical and Medical Devices The emphasis on systems-based inspections...and the IOM, QSIT, CPGM and other crucial FDA reference documents How to ensure that required documentation is in place How to interact with the investigator-DO's and DON'T's

Venue :Courtyard by Marriott Arlington Crystal City/Reagan National Airport, 2899 Jefferson Davis Highway, Arlington, VA 22202, USA

Check the event website for more details.