Monday, September 13, 2021 at 10:00 AM EDT
Tuesday, September 14, 2021 at 3:00 PM EDT

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Webex - virtual conference

This conference has been confirmed.  You will receive the Webex code as well as the final conference agenda one week prior to the conference.



Mary Ellen Sutton 
The Microbiology Network/Pharmaceutical Microbiology Forum 
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2021 PMF Fall Forum: Microbiological Aspects of Aseptic and Non-Sterile Manufacturing

The Pharmaceutical Microbiology Forum is very excited to announce that this year's PMF Fall Forum will be held virtually on September 13 and 14.

This year’s PMF Fall Forum spans aseptic and non-sterile pharmaceutical manufacturing, as well as medical devices.  Topics to be presented represent value to all these industry sectors.  Conference topics include:

  • Product formulations: microbial control and adequacy of formulations
  • Annex 1 revisions: revisions affecting cleaning and disinfection (including validation), and continuous viable sampling
  • Development of an aseptic gowning program
  • Control of visible particle contamination in sterile devices
  • Non-sterile microbial risk training for manufacturing
  • The value of having a Sterility Assurance group in an aseptic filling facility

Although it is always better to meet in person, the PMF has had great success with our last two virtual conferences and we hope you will join us to hear presentations from our eight industry thought leaders who are excited to present these updated topics. 

In an effort to make this virtual event more cost effective, we are offering a "buy one get one free" registration fee.


Microbiology laboratory supervisors and microbiologists responsible for testing and release of Pharmaceutical, Biologic, Medical Device, Dietary Supplement and Cosmetic products

Regulatory and Quality compliance personnel responsible for auditing and ensuring GMP compliance of manufacturing facilities and microbiology laboratories, including contract manufacturers and laboratories

Manufacturing, Engineering and Validation personnel responsible for contributing to microbiology laboratory and QC Microbiology GMP operations

GMP trainers 

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.



Robert Westney, Moderator

Director of Quality and Operations, Cryologics, Inc.; Principal Consultant, Westney & Associates Consulting, LLC

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).

Donald English   

Private Consultant, 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.


Tim Cser

Senior Technology Specialist, MilliporeSigma

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.

Dilip Ashtekar, Ph.D.   

Chief Consultant, RCMS Consulting Services, LLC

Dr. Ashtekar is a results-oriented collaborative and industry recognized expert leader in microbiology and sterile product manufacturing, with over 30 years of a successful and proven record of increasing responsibilities in leading pharmaceutical small molecule, biotechnology (monoclonal antibodies), biologically-derived protein therapeutics, cell therapy, plasma fractionation and plasma-based products, and vaccine industries.  He is a member of the United States Pharmacopeia (USP) Expert Microbiology Committee (2010-Current). In addition, he serves as one of the key experts of several Parenteral Drug Association (PDA) taskforces and has co-authored several Technical Reports, including Technical Report No. 13, “Fundamentals of an Environmental Monitoring Program”, and Technical Report No. 33, “Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods”

Crystal Booth, M.M.

Regional Manager, PSC Biotech Corporation

Crystal M. Booth, M.M., is a Regional Manager at PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and Quality Assurance.  She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award-winning technical writer and author of the PDA 2017 book, “Method Development and Validation for the Pharmaceutical Microbiologist”.  During her career, Crystal has worked in microbiology, consulting, Quality Assurance, CDMOs, R&D, and Quality Control laboratories. Crystal has developed and validated numerous microbiological methods and has worked with many different product types. 

Andrew Dick

Vice President Global Plant Hygiene, KDC/One

Andrew has a combined 25 years of experience within medical microbiology, food microbiology and pharmaceutical microbiology, including Quality management of manufacturing sites and laboratories.  He is a member of the PDA, PCPC and PMF. He has recently written a book, “Contamination Prevention for Nonsterile Pharmaceutical Manufacturing”, published by the PDA in 2018. He has co-authored a technical report with the PDA, TR No. 67, “Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics”.  He has a BS in Medical Technology from Kean University and a MS in Microbiology from Wagner College. 


Robert Guardino 

Principal Microbiology Consultant, MicroGuard Consulting 

Mr. Guardino is currently the founder and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical, Compounding Pharmacies, and Biotechnology industries with microbiological compliance and concerns.  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.  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 and supervised an industrial microbiology lab for five years.  His Quality System / Good Manufacturing Practice Regulations experience span over 20 years, and his areas of expertise include a broad array of GMP Microbiology topics.  He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.


Jim Polarine  

Senior Technical Service Manager, STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years.  His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient.   Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee.  Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course.  Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.  He is also a leader on the PDA’s Chapter Council Steering Committee. 

Randy Hutt 

Private Consultant, MicroDoc LLC

Dr. Randy Hutt has over 40 years of experience in the Pharmaceutical and Biological industries, management in pharmaceutical companies such as American Regent, Inc. (formerly called Luitpold Pharmaceuticals, Inc.), Wyeth-Lederle, Burroughs Wellcome, and Schering Plough.  Currently, Dr. Hutt is is an independent consultant.  Previously, she was Head of Sterility Assurance (SA), which provides an oversight function for assurance of aseptic conditions and microbial control. Prior to that, Dr. Hutt was Associate Director of Sterility Assurance and Microbiology, which included the laboratory and environmental monitoring at Luitpold, and has over 20 years of QA/QC experience including that at other companies.  In addition, she has 10 years of aseptic production management experience and several years of consulting, both in the US and internationally, performing pharmaceutical microbiological Investigations, cGMP audits, and training on how to perform audits. She has given presentations on Microbial Investigations to the Parenteral Drug Association (PDA), the Pharmaceutical Microbiology Forum (PMF) and the Institute of Validation Technology (IVT).  Her Ph.D. is in Microbiology, specializing in viruses, particularly Herpes viruses, from the Hershey Medical Center (part of Penn. State University).

Tentative Agenda for the 2021 PMF Fall Forum:

Current Trends in Nonsterile and Aseptic Manufacturing


Monday, September 13



10:00 -  10:15 am

Welcome –  Robert Westney, Moderator

10:15 - 11:15 am

The Value of Having a Sterility Assurance Group in an Aseptic Filling Facility

Dr. Randy Hutt

11:15- 12:15 pm

Annex I Revisions Affecting Cleaning and Disinfection, and Disinfectant Validation

 Jim Polarine

12:15 - 12:30 pm

Break/Sponsor Presentation

12:30 -  1:30 pm

Control of Visible Particle Contamination in Sterile Devices

Dilip Ashtekar

1:30   -  2:30 pm

Viable Air Sampling and Annex 1: What is Continuous Viable Sampling?

Tim Cser




Tuesday, September 14


10:00 - 10:15 am

Opening Remarks

Robert Westney

10:15 - 11:15 am

Product Formulation and Microbial Control

 Bob Guardino

11:15 - 12:15 pm

Non-Sterile Microbiological Risk Training for Manufacturing

 Andrew Dick

12:15 - 12:30 pm


12:30 -  1:30 pm

Preservative Adequacy of Product Formulations

 Don English

1:30  -   2:30 pm

Developing an Aseptic Gowning Program

 Crystal Booth

2:30  -   3:00 pm

Panel Discussion/Conference Concludes