With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

Date : 3rd August 2017 to 4th August 2017

Place : United States, Irvine

Website :https://www.eventbrite.com/e/change-control-best-practices-avoiding-unintended-consequences-of-changes-com-tickets-33511027385?aff=NDT

Contact Person:Paula Edwards

Description:

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval. will be held in Irvine,United States on date 2017-08-04

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Deadline for abstracts/proposals : 1st August 2017

Keynote Speakers : Andrew Campbell Pharmaceutical Consultant - Quality & Compliance Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regula

Conference Highlights :Understand regulatory requirements and FDA expectations for change control Understand the purpose of change control Identify what types of changes are /are not subject to change control Properly describe a change Properly justify a change Develop a comprehensive change execution plan Conduct a proper change risk assessment Accurately execute a change Accurately implement a change Develop a full change control package Utilize critical thinking skills throughout the change control proces

Venue :Irvine, CA, United States

Check the event website for more details.