When

Monday, May 4, 2020 at 7:00 AM EDT
-to-
Tuesday, May 5, 2020 at 3:00 PM EDT

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Where

SHERATON TAMPA RIVERWALK HOTEL 
200 North Ashley Drive
Tampa, FL 33602

Reservations: 888-236-2427

Mention "PMF Conference" when you call to reserve your room at the group rate of $159 nightly. This rate expires April 13th.

This conference has NOT YET been confirmed. Once we have met our minimum enrollment, an email will be sent to all registrants. We recommend you wait to make airline reservations until you have received the confirmation email.
NEAREST AIRPORT: TPA

 
Driving Directions 

Contact

Mary Ellen Sutton 
Microbiology Network
585-210-8336 
msutton@microbiologynetwork.com 
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2020 PMF Environmental Monitoring Summit

Detection, Assessment, Objectionables and Bcc

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:

  • Objectionable microorganisms in non-sterile facilities
  • 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)
  • Testing microorganisms found during Environmental Monitoring 
  • Chemical contamination of air, water, steam and gases
  • Unusual Environmental Monitoring situations

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

Schedule


 

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).

Christine Massaro 

Christine Massaro is an Associate Director in the Global Sterile and Microbiology Quality Assurance group at Merck since 2017.  She currently supports global regulatory inspections regarding laboratory testing and develops divisional microbiological standards and procedures. She has expertise in microbiological laboratory testing and global compendial compliance, non-sterile contamination prevention, and microbial control of aseptic processing.

Prior to her role at Merck, she spent time at Johnson and Johnson overseeing external contract laboratories and CMO microbiological testing and supported investigations. She performed non-sterile microbiological risk assessments for both labs and manufacturing.  

Her other experience includes microbiological test method and validation troubleshooting, addressing regulatory filing test method inquiries, auditing of laboratories, supporting regulatory inspections, aseptic and sterile tissue processing, development of dose auditing programs, and implementation of cleanroom behavior training programs. 

Christine has published in the PDA Newsletter on managing microbiological expectations in raw material suppliers and presented on this topic at local Metro chapter PDA events.    

Christine has earned her B.S in Biology and an M.S. degree in Microbiology from Wagner College, Staten Island NY.

 

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 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.

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.