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    Preparation for GMP Inspections by Regulatory Agencies - 2017

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    Website http://www.compliance4all.com/control/w_product/~product_id=501225LIVE?channel=mailer&camp=Webinar&A | Want to Edit it Edit Freely

    Category gmp, cgmp regulations, Medical device compliance webinar, healthcare regulatory compliance trainings, Technical operations, online compliance trainings, pharmaceutical regulatory affairs, regulatory affairs professionals society

    Deadline: April 04, 2017 | Date: April 05, 2017

    Venue/Country: Fremont, U.S.A

    Updated: 2017-02-24 18:47:14 (GMT+9)

    Call For Papers - CFP

    Overview:

    This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies.

    Why should you Attend:

    Good manufacturing practice (GMP) is the minimum standard that a

    manufacturer must meet in their production processes.

    This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.

    Areas Covered in the Session:

    Types of Inspections (for cause, pre-approval, periodic ) > API & FDF

    Notification Timing

    Foreign Facilities

    What to expect during Inspection

    Do a company audit as the FDA would (fall dress rehearsal)

    Make adjustments as needed/address issues/take needed actions

    Managing the Inspection

    Inspection on follow-up

    Who Will Benefit:

    Design Engineers

    Manufacturing

    Supply chain

    Technical operations

    Quality control

    Quality assurance

    Regulatory affairs

    Speaker Profile:

    Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department.

    Contact Detail:

    Compliance4All DBA NetZealous,

    Phone: +1-800-447-9407

    Email: supportatcompliance4All.com


    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.