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    FDA Inspections: What Regulations Expect

    View: 113

    Website https://goo.gl/bubybp | Want to Edit it Edit Freely

    Category cgmp compliance, cgmp guidelines, fda compliance, fda gmp guidelines, fda guidance

    Deadline: December 13, 2017 | Date: December 13, 2017

    Venue/Country: CO, U.S.A

    Updated: 2017-11-17 15:30:41 (GMT+9)

    Call For Papers - CFP

    OVERVIEW

    In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required documentation, formats, archiving, as well as how to respond to inspection and audit results.

    WHY SHOULD YOU ATTEND

    One should attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. One will gain a better understanding of the parameters, approaches, and concerns of FDA inspectors. One will also gain a more in depth understanding of how to prepare for unannounced FDA audits and inspections.

    AREAS COVERED

    • The inspection Process

    • Legal Issues

    • Inspection Checklists

    • Part 11 Signatures

    • Archiving

    • Audit Trails

    • Mock Audits

    • Documentation

    • Report Writing

    • Responding to FDA 483’s

    WHO WILL BENEFIT

    • Quality Assurance Managers and Supervisors

    • Validation managers and Supervisors

    • Engineering Managers and Supervisors

    • Regulatory Affairs Managers and Supervisors

    • Manufacturing and Operations managers and Supervisors

    • Laboratory managers, supervisors and analysts

    • IT managers and staff

    • Consultants

    • Senior quality managers

    • Validation engineers

    • Manufacturing engineers

    • Production engineers

    • Design engineers

    • Process owners

    • Quality engineers

    • Quality auditors

    LEARNING OBJECTIVES

    Attending the webinar will give you a thorough understanding of the expectations and procedures of FDA inspectors. It will help you understand and devise strategies to be prepared for and manage inspections in manufacturing facilities.

    For more detail please click on this below link:

    https://goo.gl/bubybp

    Email: supportattrainingdoyens.com

    Toll Free: +1-888-300-8494

    Tel: +1-720-996-1616

    Fax: +1-888-909-1882


    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.