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    FDA's New Enforcement of 21 CFR Part 11- by Dr Ludwig Huber

    View: 317

    Website https://compliance2go.com/product/?topic=fdas-new-enforcement-of-21-cfr-part-11-dr-ludwig-huber | Want to Edit it Edit Freely

    Category Medical Device , Pharmaceutical

    Deadline: May 27, 2015 | Date: May 27, 2015

    Venue/Country: Houston, U.S.A

    Updated: 2015-05-08 20:36:58 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

    Topics:

    FDA’s current inspection and enforcement practices

    FDA’s new interpretation: learning from FDA inspection reports

    Strategy for cost-effective implementation of Part 11: A six step plan

    Recommended changes to existing Part 11 programs to reduce costs

    Justification and documentation for the FDA and your management

    Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

    Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

    How to prepare your company for Part 11 Inspections

    Who will benefit :

    IT managers and system administrators

    QA managers and personnel

    Analysts and lab managers

    Validation groups

    Software developers

    Validation professionals

    Training departments

    Documentation department

    Consultants

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    75 Minutes Live Presentation

    Certificate of Attendance


    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.