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Sep
16

Change Control Best Practices - Avoiding Unintended Consequences of Changes

 
 Seminar/trade show (noCPF)

When:

  16 Sep 2021 through 17 Sep 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/fda-change-control-expectations-best-practices-seminar-training-80244SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Education / Legal / Other - Education

Keywords:


Event description:

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts. It is therefore critically important to assure that changes are properly described, justified, assessed for risk, implemented, and documented. 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. This seminar will help all personnel involved in proposing, assessing, and implementing changes to un... Read more

Posting date:

19 August 2021  |  185 views

Placement:

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