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This free webinar will provide insights into data integrity considerations in life science manufacturing operations. We provide an overview about most current guidelines like PDA's TR 84 and ISPE Good Practice Guide on Manufacturing Records. The changing regulatory environment with update in ICH Q9 (Revision 1) and the new Annex 11 Revision Concept paper (EMA, PIC/S) will be investigated .
Finally, we will give several examples of regulatory enforcement from very current FDA 483s and Warning Letter observations and answer frequently asked questions bringing in our vast experience in this topic.