Program Description:
The primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices.
Faced with an impending audit or inspection, how do you prepare? This webinar will provide an overview of what to expect and how to prepare for an audit or inspection. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.
Upon completion of this Webcast, attendees should be able to:
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describe the anatomy of a regulatory inspection.
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recognize how to best prepare and manage expectations.
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review tools to assist in preparation for an inspection.
Target Audience: CRCs, PIs, CRAs, QA and anyone else involved in site inspections
Agenda:
6:30-6:40 Welcome and Chapter Meeting
6:40-8:00 Educational Program and Q&A
Cost: Complimentary for NY Metro Chapter Members / $25 Non NYM Chapter Members.
Registration: Register at Eventbrite. Log in information will be sent one week prior to the event.
Contact hours: 1.5 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours. Click here to register for contact hours.
Contact Hour Cost: Complimentary for NY Metro Chapter Members/$15 ACRP Members/$30 Non- Members
To receive contact hours: Purchase the contact hours on the ACRP NY Metro Chapter website the up to two weeks after the event. Between 1 and 30 days after attending the program, go to https:// acrp.digitellinc.com/acrp/login to complete the evaluation. You can also get to it by going to the “My Courses” link and clicking on the button for Chapter Events (the button on the left side). Once you are on the platform, click on Chapter Events on the left, click on the correct event, select the CE Information tab and click on the “Take Evaluation” button. It takes one business day for the information to refresh in your account.