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...
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Posting date:
25 May 2021 | 178 views
Placement:
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