Current Regulatory Expectations
Pertaining to Environmental Monitoring


December 1st, 2021

11:00 AM – 12:30 PM EDT

Current regulatory thinking about environmental monitoring as outlined in the 2020 Draft of EU Annex 1 focuses on risk assessment across all the key elements of the program. This includes understanding airflows to select risk-based sampling sites, criteria for monitoring equipment, level of microbial identification and mainly understanding trends to evaluate facility condition, personnel practices, predominance of microorganisms; all in an effort to save product from contamination and patient from harm.

Additionally with emerging and reemerging infections and the direction of regulators per FDA’s draft guidance for non-sterile products it is beneficial to evaluate environmental monitoring practices for non-sterile facilities.  Risk based monitoring and thorough evaluation of cleanroom flora and trends will help in protecting the non-sterile products form ingress of objectionable microorganisms.

Join industry leaders Ziva Abraham and Parsa Famili for a fireside conversation as they share war stories of their experience transforming environmental monitoring programs in some of Life Science’s most influential companies. Grab a cup of coffee and sit down to listen to their frank dialog about FDA’s draft guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing, and EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft,) and the future of environmental monitoring in sterile and non-sterile manufacturing. 

SPEAKERS


Ziva Abraham

CEO, Microrite, Inc.

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.


Parsa Famili, MSc

President & CEO, NOVATEK INTERNATIONAL


Parsa Famili, Is the President and CEO of Novatek International.  Prior to joining Novatek, he held senior management positions in quality departments of several North American pharmaceutical companies.  He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits.  He was also an instructor of Chemistry and Biochemistry at Vanier College in Montreal, Quebec Canada.  Mr. Famili has published chapters and articles in various industry journals and publications.  His latest contribution “User Requirements & Implementation of a Risk-Based, Compliant Stability Management System” in Methods for Stability Testing of Pharmaceuticals (edited by Edited by Bajaj, Sanjay, Singh, Saranjit, 2018).  He is also an international speaker for ISPE, PDA, IVT, IPA, KENX, EXPOFARMA among many other global associations.