2021 PMF Environmental Monitoring Summit:

Connection to Product Safety and Quality

Web Conference

Please join us for the highly anticipated 2021 PMF Environmental Monitoring Summit: Connection to Product Safety and Quality. The 2021 PMF Environmental Monitoring Summit: Environmental Monitoring – Connection to Product Quality and Safety, will be a two-day WebEx conference held on April 26 and 27, 2021.

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.   We have found that the WebEx format has made it possible for more people to attend since travel expenses are not an issue.

Microbiologists play a prominent role in sampling, testing, analyzing and interpreting results for products that are used by millions of individuals around the world.  One role for microbiologists who work in health science companies - whether the company manufactures sterile, non-sterile, cosmetic or medical devices – is to conduct environmental monitoring to determine the physical health of the facilities.  Many companies collect reams of data and generate enormous summary reports to demonstrate that their facility is in a state of control.  The data show trends, where potential problems exist and facilitate corrective actions when required.  However they do not necessarily show how, or if, Environmental Monitoring affects product safety and quality.  The theme of this summit is therefore to assist microbiologists use the data to assure product quality and safety throughout the manufacturing process.  

This conference is designed to help microbiologists, and their management teams gain insight into EM and decipher the implications of data on product quality and safety, 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 the following presentations:

Active air sampling

• Why, where, when, how?  
• What do the data tell you (product impact)?

Settling plate sampling

• Why, where, when, how?
• Pros and cons
• Regulatory expectations

Surface sampling

• Why, where, when, how?
• What do the data tell you?
• What happens when alert and action levels are exceeded (product impact)?

Personal sampling

• Why, where, when, how?
• What do the data tell you?
• What happens when alert and action levels are exceeded (product impact)?

Real-Time Detection of Chemical and Microbiological Impurities in Pharmaceutical Waters

• Trending
• Control Charts
• Determination of Alert and Action Limits 
• What happens when alert and action levels are exceeded (product impact)?

Use of EM microorganisms for growth promotion and Disinfection Efficacy (DET) Studies:

• Why?
• What organisms to use?
• How often?
• How to prepare your organisms for use in testing? What are the potential issues?

SEE ABSTRACTS HERE. 

LEARNING OBJECTIVES

Conference attendees will be able to:

• Utilize EM data to improve product quality and safety
• Decipher the differences between data obtained from different types of sampling (e.g., active air versus settling plates)
• Understand and explain why EM isolates must be used for growth promotion and disinfectant efficacy studies
• Gain a better understanding of statistical analysis
• Determine the optimal methods for setting alert and action limits
• Ask poignant questions to uncover unapparent reasons for an EM excursion
• Apply industry best practices to data
• 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.

 SCHEDULE

Day 1 - April 26, 2021

Day 2 - April 27, 2021

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 

Presentation Title:  Identification of Recovered Environments Microbial Isolates

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 

Presentation Title: The Use of In-House Microbial Isolates in Media Growth Promotion and Disinfection Efficacy Testing

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, MilliporeSigma

Presentation Title: Viable Air Sampling and Annex 1.  What is Continuous Viable  Sampling?

Tim Cser has 21 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.

Elizabeth Brockson, CAI

Presentation TItle: Considerations for Environmental Monitoring Settle Plates

Elizabeth Brockson has a background in benchtop microbiology and immunology, as well as over 7 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. She is currently a consultant with Commissioning Agents, Inc. Her roles have included microbiology, auditing, and compliance/regulatory as they pertain to global regulations including FDA, MHRA, JP, and Health Canada.

Anthony Bevilacqua, Mettler-Toledo Thornton

Presentation TItle: Real-Time Detection of Chemical and Microbiological Impurities in Pharmaceutical Waters

Dr. Anthony Bevilacqua is the Principal Scientist 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.

Tracy Ammann, Mettler-Toledo Thornton

Presentation Title: Real-Time Detection of Chemical and Microbiological Impurities in Pharmaceutical Waters

Tracy Ammann is a well-rounded microbiologist with over 9 years of professional experience working in private industry, academic, and clinical laboratories. Rapid microbiology has been the focus of her career over the last six years working with Accelerate Diagnostics, Inc. and now in Process Analytics with Mettler Toledo Thornton. Currently, Tracy leads the microbiology lab in Tucson, AZ, conducting research and development for a real-time microbial analyzer for high purity water systems. She holds a Professional Science Masters in Applied Biosciences with an emphasis in medical diagnostics and laboratory sciences and a Bachelor of Science in Microbiology from the University of Arizona, a Clinical Laboratory Sciences Microbiology Certificate from the University of North Dakota, and is certified by the American Society for Clinical Pathology in Microbiology.

Kerry Clawson, VistaPharm

Presentation Title: QC Microbiology Environmental Surface Sampling 

Kerry  Clawson worked in the pharmaceutical industry for over 20 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). He has 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.