ECA - Modern EU and FDA Validation - Continued / Ongoing Process Verification

Art-No.: A-1061
Date: 14-15 May 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
13601Parallels between Medical Device and Drug Process Validation025
13602Case Study: From Control Strategy to Trending028
13603Case Study Large Molecules: Process Valdation and Statistical Trending in Biopharmaceutical Manufacturing033
13604Case Study CPV of legacy products incl. Workshop Data Evaluation038
13605The future role of PAT, industrial IT and automation in continued process verification: Implementing a control strategy069
13914Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles058
13915Recent trends in FDA inspections, observations and warning letters036
14278Case Study Sanofi Aventis SPC as tool for CPV016
14531Ongoing Process Verification - View of an European Inspector039

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