2-Day Virtual Seminar Process Validation Guidance Requirements(FDA and EU Annex 15:Qualifications and Validation) When:Monday & Tuesday June 14- June 15,2021 Day 01 & 02(10:00 AM – 4:00PM EDT). 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 to 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 guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management,and Q10 Pharmaceutical Quality System.
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