PDA Metro: EMA's 2022 Version of Annex 1 - Preparation & Perils

PDA Metro Chapter is hosting an in-person event on EMA's 2022 Version of Annex 1 - Preparation & Perils and you are welcome to join us.

Abstract: The next revision of EMA's Annex 1 has major implications for the global production of sterile products. Regardless of whether this is the final version of the Annex or not, there are aspects that a prudent organization can implement in anticipation of their eventual inclusion. This presentation will outline practices to be addressed prior to finalization that will ease the transition. Those aspects expected to provide the greatest difficulty to compliance will be highlighted.

Presenter:  James Agalloco

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He has served as a chairman and member of numerous PDA committees. He is a frequent author and lecturer on the subject of process and computer systems validations.