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

Expired
Dates : 02 December 2021 » 03 December 2021

Place : San Jose
United States

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Organizer : Complianceonline

Topic : Health and Medicine; Regulation in Medicine and Pharmacology
Engineering and Technology; Health and Medicine;
Keywords: Manufacturing, Technology, Medicine
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 and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Topics: FDA Process Validation Guidance, EU Annex 15, Active Pharmaceutical Ingredients (APIs), International Conference on Harmonization (ICH), Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, Phase 1 IND Clinical Trial, cGMP, Process Performance Qualification (PPQ, Analytical Methodology, Warning Letter


Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) to be held in San Jose, United States between 02 December 2021 and 03 December 2021. It is organised by Complianceonline. It covers specific areas of Health and Medicine such as Regulation in Medicine and Pharmacology. Visit the website of the conference for more detailed information or contact the organizer for specific questions.
Add to calendar 2021-12-02 2021-12-03 Europe/London Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) https://www.sciencedz.net/en/conference/84836-process-validation-guidance-requirements-fda-and-eu-annex-15-qualifications-and-validation San Jose - United States Complianceonline

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