FDA Recordkeeping Requirements
View: 111
Website https://compliance2go.com/product/?pid=CP2014-339 |
Edit Freely
Category Biotechnology , Medical Device , Pharmaceutical
Deadline: August 28, 2014 | Date: August 28, 2014
Venue/Country: online, U.S.A
Updated: 2014-07-30 15:39:15 (GMT+9)
Call For Papers - CFP
DESCRIPTIONWhy you should attendMore 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 InstrumentsCampania Internacional de ComercioHealth One PharmaceuticalsEdge BiologicalsGulf PharmaceuticalsThe 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?Webinar Includes:11-step recordkeeping strategy sheetChecklist of core recordkeeping controls ? perfect for adopting into quality and supplier auditsQ/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of AttendanceDescription of the topicLearn 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 SeminarTypes of regulated records required to be keptHow to determine what documents you need to retain and for how longExample FDA enforcement citations for poor recordkeeping practicesHow to develop an FDA records retention scheduleHow to handle records maintained at your suppliersHow to deal with email and records kept electronically vs. in hardcopySOPs and policies you need to haveWho will benefitQuality managers and professionalsRegulatory affairs managers and professionalsDocument control/records management professionals and managersAnyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.