Please join us for the highly anticipated 2020 PMF Environmental Monitoring Summit. Last year’s EM Summit was repeatedly recognized as one of the best conferences attended by many who have been in the industry for decades. Because of these high reviews, we are hoping to surpass last year’s success.
Microbiologists play a prominent role in sampling, testing, analyzing and interpreting results for products that are used by millions of individuals around the world. For products manufactured under cGMP guidelines, the EM criteria are usually quite clear – either the environment is within specified limits or exceeds the limits. What is not clear is how a result outside the limits may or may not affect product quality and safety.
This conference is designed to help microbiologists, and their management teams, gain insight into EM and decipher the implications of data that may be at or beyond established limits, as seen from the perspective of industry veterans who have been there, done that.
This conference will focus on environmental monitoring in support of manufacturing including:
LEARNING OBJECTIVES
Workshop attendees will be able to:
Speakers
Frank Settineri, Moderator
Frank Settineri has more than 40 years of pharmaceutical manufacturing, business and compounding pharmacy experiences. He founded Veracorp LLC in 2006, a consulting firm specializing in GMP compliance, microbiological investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter issues and outsourcing of suppliers, contract laboratories and manufacturing sites. Frank is adept at finding and correcting the source(s) of MDDs and responding to FDA 483s and warning letters that result in both interim controls and sustained cGMP compliance. His client base includes real and virtual start-ups, compounding pharmacies, sterile facilities, oral, solid and powder dosage form manufacturers, API manufacturers, medical device companies and microbiology laboratories. His firm has assembled teams of multidisciplinary experts that reorganize quality systems and corporate structures.
Donald J. English, Microbiological Quality Consulting LLC
Donald J. English has over 40 years of experience at the bench and managerial levels in industrial microbiology and has worked in the Research and Development and Quality Control Microbiology Laboratories at Avon Products, Inc., GlaxoSmithKline Consumer Healthcare and Merck and Co.
He is currently a consultant that provides consulting services to cosmetic/personal care, dietary supplement and pharmaceutical industries. Has extensive knowledge in the following areas: how to adequately preserve product formulations by using traditional and non-traditional/alternative preservative systems; cGMP auditing of Quality Control Testing Laboratories (e.g. in-house and contract) and non-sterile manufacturing facilities; hygienic design of manufacturing utility systems (e.g. compressed air and water) and manufacturing equipment; risk assessment; microbial test method development and validation; microbial content testing of raw ingredients and finished product formulations; microbial identification of isolates; implementation of rapid microbiological test methods; root-cause investigations of microbiological contamination issues in product formulations; and cleaning and sanitization practices of a manufacturing facility and equipment.
Bob Westney
Bob is the Founder and President of Cryologics Inc., Principal Consultant for Westney & Associates Consulting LLC, and a member of the Microbiology Network consortium of consultants. He has more than 30 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He holds a Master of Science degree from Temple University in Quality Assurance / Regulatory Affairs. He is Regulatory Affairs Certified (RAC) and is a Certified Manager of Quality and Organizational Excellence (CMQ / OE). He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ).