01:00 PM TO 02:30 PM – EST DURATION: 90 MINUTES
Live webinar on "FDA Recordkeeping Requirements" DESCRIPTION
Why you should attend More than 35% of FDA warning letters cite poor record and document controls. And in the first part of 2012, FDA cited five companies just for poor recordkeeping of regulatory records: Ningbo Huahui Medical Instruments Campania Internacional de Comercio Health One Pharmaceuticals Edge Biologicals Gulf Pharmaceuticals The ugly truth about FDA compliance is that the agency doesn’t care what you say you did, FDA investigators only look at the records and documents you’ve kept. You cannot hope to pass an FDA inspection without the right records.So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
11-step recordkeeping strategy sheet Checklist of core recordkeeping controls – perfect for adopting into quality and supplier audits Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Certificate of Attendance
Live One Dial In - One $189Attendee One Dial In Unlimited attendance (To be arranged in a $249Conference room/Meeting room. Note : Only One Dial In Allowed)
Combo Combo 1 (One Dial In - Unlimited $329attendance + On Demand Recorded Session) Combo 2 (One Dial In - Unlimited $349 attendance + Training CD)
Recorded On Demand ( 90 Days of online $289Streaming access available after the live session ) Play Back Unlimited Views ( Recorded file $319 available for download after the live session ) Get Training CD $359
Multiple Location $109 Multiple location 9 - Up to 5 Dial in $499 allowed
Description of the topic Learn the SOPs and policies to have, how to incorporate risk assessments, how to ensure each of your SOPs generate clear records as proof of compliance, and get the details of an effective FDA recordkeeping program. Learn the types of documents FDA expects you to retain, and where to go to identify the specific documents, correspondence, and records your company is required to keep. Areas Covered In the Seminar Types of regulated records required to be kept How to determine what documents you need to retain and for how long Example FDA enforcement citations for poor recordkeeping practices How to develop an FDA records retention schedule How to handle records maintained at your suppliers How to deal with email and records kept electronically vs. in hardcopy SOPs and policies you need to have Who will benefit Quality managers and professionals Regulatory affairs managers and professionals Document control/records management professionals and managers Anyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
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