2019 PMF Environmental Monitoring Summit

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:

• Non-viable vs viable monitoring
• Developing an EM program
• Sample site selection
• EM in non-sterile facilities
• EM in sterile facilities
• Setting contamination control limits
• Trends
• Recent  FDA Observations
• Investigating excursions and determining product impact
• TOC / conductivity
• EM in the Laboratory

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

WHO SHOULD ATTEND

The meeting will be of particular interest to microbiologists and microbiology laboratory managers, contract laboratory microbiologists and managers, cosmetic, medical device and pharmaceutical manufacturers, and individuals responsible for disposition of products that are dependent upon EM programs. 

VENUE:

DoubleTree Suites by Hilton Hotel Tampa Bay

3050 N Rocky Point Dr W

Tampa, FL 33607

The guest room reservation link will be included on the confirmation email you receive after registering. 

AIRPORT CODE: TPA

 

Register Now! 

Cancellation Policy: PMF and Microbiology Network reserve the right to modify or cancel any event.  In the event of a cancellation, registrants will be notified as soon as possible and all registration fees will be reimbursed.  PMF and Microbiology Network are not responsibile for lost airfare due to cancellations.  Refund requests received at least 14 days prior to the date of the event will receive a full refund, less a $200 processing fee.  After that, no refunds will be issued.You may enroll a substitute at any time before the conference begins.

Schedule

Speakers

Frank Settineri, Moderator 

Frank Settineri has a B.S. and an M.S. in Microbiology from Rutgers Univsersity.  With 30 years of pharmaceutical manufacturing and business experience, he is an authority on GMP compliance, validation planning, outsourcing, and microbial and sterile and non-sterile manufacturing solutions.  Frank has qualified testing laboratories and finished product supplier sites through GMP audits.  He has investigated and rectified microbial contamination and sterility problems.  He is a Quality Assurance expert on laboratory and sterile and non-sterile manufacturing operations.  He has remediated businesses and brought them back on line.  

 He has over 30 years of pharmaceutical manufacturing and business experience, is an authority on GMP compliance, deviations and investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter, and outsourcing of suppliers, contract laboratories and manufacturing sites.  He is particularly adept at writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance.  He is the principal of Veracorp LLC, whose clients include virtual start-ups, compounding pharmacies, API manufacturers, solid and liquid oral dosage manufacturers, sterile facilities, medical device operations and microbiology laboratories.  Veracorp LLC assembles teams of multidisciplinary experts and often leads its client’s  quality system remediation initiatives.

Robert F Guardino, MicroGuard Consulting

Mr. Guardino is the founder and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries, and Compounding Pharmacies with microbiological compliance and concerns. In this role, Mr. Guardino has served as an international consultant on four continents over the past seven years. Prior to this role, Mr. Guardino served as the Director of Microbiology for AAIPharma Services Corp. where he oversaw a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role, Mr. Guardino interacted with many clients and client companies offering consulting and testing services. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span over 25 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological method suitability and testing requirements; release and stability requirements and testing; down-stream / purification process contamination and control strategies for biotechnology products; disinfectant qualification; water system and environmental validation; and compounding pharmacy regulations and microbiology-related requirements. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.

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.

Randy Hutt, Ph.D., Luitpold

Dr. Randy Hutt has over 35 years of experience in the Pharmaceutical and Biological industries, management in pharmaceutical companies such as Luitpold Pharmaceuticals (now called American Regent), Wyeth-Lederle, Burroughs Wellcome, and Schering Plough.  Currently, Dr. Hutt is Head of Sterility Assurance (SA), which is part of the Quality Assurance group.  SA provides an oversight function for assurance of aseptic conditions and microbial control. Dr. Hutt chairs meetings of the Sterility Assurance Task Force where all issues/concerns and plans for the future are discussed.  Her group writes investigations for Environmental and Personnel Monitoring and writes protocols and reports for technical studies, such as bringing in new gowns and gloves.  In addition, SA writes quarterly and annual trend reports to review viable and non-viable data in the Aseptic Processing Area and authored and revises as a living document, the Master Plan for Microbial Control. The group put together an FMEA (Risk Assessment) to reduce ingress of microorganisms into the facility.  Based on that, proposals are made for changes to the facility or processes.

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).

Anthony Bevilacqua, Mettler-Toledo Thornton          

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 18 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.