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Drug Product registration process in the US MasterClass

Drug Product registration process in the US MasterClass

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The Drug Product registration process in the US MasterClass covers topics such as: What are the possible types of FDA Audits based on scope, FDA structure and its methodologies on submissions evaluation, How to organize the upcoming inspection, How to assess the status of the plant and reach the adequate level for the FDA audit, Management of the response to audit observations The Drug Product registration process in the US MasterClass brings together: Quality Assurance, Quality Control, Engineering, Manufacturing, CSV, IT, TRandD, Regulatory Affairs

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Full Name
Drug Product registration process in the US MasterClass
Start Date
2024-09-16
End Date
2024-09-19
Place Name
GLC - Global Leading Conferences
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GLC - Global Leading Conferences
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Website
https://glceurope.com/events/pharma/drug-product-registration-process-in-the-us-masterclass?utm_source=clocate_shara&utm_medium=media_partner&utm_campaign=DPRPUSMC

The Drug Product registration process in the US MasterClass covers topics such as:

  • What are the possible types of FDA Audits based on scope
  • FDA structure and its methodologies on submissions evaluation
  • How to organize the upcoming inspection
  • How to assess the status of the plant and reach the adequate level for the FDA audit
  • Management of the response to audit observations

The Drug Product registration process in the US MasterClass brings together:

  • Quality Assurance
  • Quality Control
  • Engineering
  • Manufacturing
  • CSV
  • IT
  • TR&D
  • Regulatory Affairs

The Drug Product registration process in the US MasterClass will be held on 16-19 Sep 2024.

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