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.

WHO SHOULD ATTEND

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.

Speakers

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).

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

Tentative Agenda for the 2021 PMF Fall Forum:

Current Trends in Nonsterile and Aseptic Manufacturing