2020 PMF Environmental Monitoring Summit

Detection, Assessment, Objectionables and Bcc

Web Conference

Due to the Covid-19 pandemic, the 2020 PMF Environmental Monitoring Summit has been converted into a WebEx conference. This online summit will take place on May 5, 6, & 7.

Please join us for the highly anticipated 2020 PMF Environmental Monitoring Summit: Detection, Assessment, Objectionables and Bcc. Last year’s EM Summit was recognized as one of the best conferences attended by many who have been in the industry for decades. Our presenters are eager to bring another excellent event to you this year, albeit in a different format.

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 web 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. Because PMF conference attendees appreciate the discussion and Q&A aspect of these small conferences, we have scheduled time for these to take place in this new format.

This conference will focus on environmental monitoring in support of manufacturing including:

• Environmental Monitoring in sterile facilities
• Environmental Monitoring measurement – techniques and devices
• Qualifying an Environmental Monitoring Program for Non-Sterile Manufacturing: A Case Study
• Monitoring for Burkholderia cepacia complex (Bcc)
• The New Annex 1 Revision and the Impact on Using Rapid Methods for Environmental Monitoring
• Environmental Monitoring and the Laboratory
• Chemical contamination of air, water, steam and gases
• Unusual Environmental Monitoring situations
• COVID-19 Discussion session

LEARNING OBJECTIVES

 Workshop attendees will be able to:

•     Understand the regulatory requirements for EM
•     Proficiently analyze EM data
•     Ask poignant questions to uncover unapparent reasons for an EM excursion
•     Determine the effect of an EM excursion on product safety and efficacy
•     Determine optimal sampling sites and frequencies
•     Apply trending data to the analysis
•     Apply industry best practices to data
•     Understand the implications of a product failure due to EM
•     Be confident in defending their position, based upon scientific discipline
•     Be a better asset to their company

 

SEE PRESENTER'S ABSTRACTS HERE. 

This document will be updated, so check back for additional information.

 SCHEDULE

Day 1 - May 5, 2020

 

Day 2 - May 6, 2020

 

Day 3 - May 7, 2020

 

 

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).

Timothy Cser, EMD Millipore 

Tim Cser has 20 years of experience in the QC microbiology industry spanning microbial ID, sterility, bioburden, EM, mycoplasma testing, and rapid microbiology testing.  Tim currently works at MilliporeSigma as a Senior Technology Specialist and previously worked at Biolog, a microbial identification company.  Tim has spoken at PDA events regarding environmental monitoring as well as published 2 chapters in the PDA Environmental Monitoring book.  Tim holds a B.S. in Microbiology from California Polytechnic State University, San Luis Obispo.

Anthony Grilli, Focus Laboratories
 
Tony holds a graduate degree in microbiology from Rutgers University.  For over 25 years, Tony has managed several contract laboratory organizations to regulatory and financial success.  Mr. Grilli has advised clients on matters of regulatory compliance, technical method validation, and microbial remediation.   He has hosted and conducted audits, authored protocols, designed laboratories, developed laboratory quality systems, remediated 483 observations, and developed Lean Sigma laboratory processes.  He  has published in peer reviewed journals and has presented at seminars.  He is active in several organizations, including President Elect of the Metro Chapter of Parenteral Drug Association (PDA), Controlled Environment Testing Association (CETA) and American Standard Test Methods (ASTM).

Dr. Anthony Bevilacqua is the Head of Research and Development at Mettler-Toledo Thornton.  He  earned a doctorate in Analytical and Physical Chemistry from Tufts University.  He has been at Thornton since 1994, leading the instrumentation development for Thornton in several areas of R&D including improved high temperature conductivity measurements, the impact of CO2 on pure water, use of ultrapure water (UPW) as a conductivity solution standard, development of digital sensors, and the expansion of real-time analytical parameters (conductivity, TOC, microbial detection, ozone, sodium, and silica) for measurement and control of high purity water systems, including pharmaceutical water systems.

Kerry Clawson, VistaPharm

Kerry Clawson Worked in the pharmaceutical industry for 19 years with various product formulations including non-sterile oral formulations (liqui-gel caps, unit dose solutions and suspensions), non-sterile topical creams and sprays and sterile (solutions, suspensions, ointments, injections). I have had roles working in QC Microbiology with product and material testing, aseptic training and monitoring, sterility testing and validation (steam, EO, Gamma, and E-beam) validation for facility systems (HVAC, purified and WIFI water systems, compressed gases) and environmental programs for both new builds and renovations of aseptic and non-sterile GMP manufacturing areas.

 

Michael Miller, Microbiology Consultants

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). For more than 30 years, he has held numerous R&D, manufacturing, quality and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. In his current role, Dr. Miller consults with multinational companies in providing technical, quality and regulatory support for rapid methods, sterile and non-sterile pharmaceutical manufacturing, ATMPs, contamination control and investigations, and GMP compliance.