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    FDA Recordkeeping Requirements

    View: 109

    Website https://compliance2go.com/product/?pid=CP2014-339 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: August 28, 2014 | Date: August 28, 2014

    Venue/Country: online, U.S.A

    Updated: 2014-07-29 20:49:03 (GMT+9)

    Call For Papers - CFP

    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?

    Webinar Includes:

    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

    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


    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.