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    Implementing the Best Practices for FDA Inspection Preparation and Management

    View: 221

    Website https://compliance2go.com/product/?pid=CP2014-355 | Want to Edit it Edit Freely

    Category Medical Device , Pharmaceutical

    Deadline: October 07, 2014 | Date: October 07, 2014

    Venue/Country: online, U.S.A

    Updated: 2014-09-19 16:46:02 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar is intended to help you get familiar with how to implement the best practices for FDA inspection preparation and management integrated with emotional intelligence (EQ) so that a firm’s preparation and readiness for an FDA (BIMO) inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization.

    This webinar will discuss what you need to be aware and become familiar with for your job to get done easier and in a less burdensome, straight-forward manner. The best practices for FDA BIMO inspection preparation and readiness purposes including a list of Dos and Don’ts before, during and after the inspection will be discussed. In addition, some key factors contributing to the overall efficiency and effectiveness of your FDA inspection readiness and management program will also be discussed.

    At the end of the webinar, you can have a great opportunity to drastically improve your current FDA inspection preparation and readiness program or equivalent with awareness and confidence.

    Areas Covered in the Session:

    Statutes and Regulations

    Definitions

    FDA Manuals

    Regulatory Requirements for Compliance

    FDA BIMO Inspection: Scope and Depth

    Inspection Types and Categories

    Inspection Classification

    Inspection Process

    Hosting an FDA Inspection

    How to Answer Questions

    FDA Forms 482 and 483

    Dos and Don’ts Before, During and After FDA Inspection

    Responding to 483: Best Practices

    Misconception and Frequent Mistakes

    Enforcement Cases

    Improving Awareness and Exercising Sound Judgment

    Good Business and Employment Practices

    Transparency, Accountability and Integrity

    Practical, Actionable and Sustainable Recommendations: Best Practices

    Conclusion

    Who will benefit: (Titles)

    CEOs

    VPs

    Compliance Officers

    Attorneys

    Regulatory Affairs

    Clinical Affairs

    Quality Assurance

    R&D

    Consultants

    Contractors/Subcontractors

    Anyone Interested in the FDA (BIMO) Inspection Process

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    60 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.