About
THE WEBINAR IS FULL - IF YOU WANT TO ASK FOR ANOTHER OPPORTUNITY TO PARTICIPATE, PLEASE REACH OUT TO:
ulrich.koellisch@gxp-cc.com

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.
Presenters
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GxP-CC
Tame Compliance, Avoid Penalties, & Trim Costs
Get the Customized GxP Compliance Strategy You Need In the Pharmaceutical, Medical and Dental Industries
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Dr. Ulrich Köllisch
Presenter
Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous eight years. He has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area and precedes special interest groups and affiliations. Ulrich combines regulatory knowledge with hands-on implementation experience for Data Integrity programs. He considers technical aspects to enable Data Integrity like processes and systems and has a focus on the human factor which is influenced by the companies’ quality culture and can be improved with awareness programs.
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James Francum
CEO
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