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Jun
14

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

 
 Seminar/trade show (noCPF)

When:

  14 Jun 2021 through 15 Jun 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/fda-eu-annex15-ich-process-validation-qualification-cgmp-ppq-seminar-training-80375SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Education / Legal / Other - Education

Keywords:


Event description:

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science a... Read more

Posting date:

25 May 2021  |  164 views

Placement:

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