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PMF Fall Forum 2018




We are very excited to announce this year's PMF Fall Forum, "Current Trends in Pharmaceutical Microbiology".  Leading industry experts will present and discuss topics relating to current regulatory, compendial and enforcement trends in Quality Control Microbiology.

Our industries, relying on compliance with current Good Manufacturing Practices, are subject to the ever-evolving continuum of our regulatory environment.  This conference will provide you with a perspective on several current trends relating to QC Microbiology.  We are privileged to have well-recognized industry Subject Matter Experts present their knowledge and experiences with tackling the challenges associated with these trends, ranging from QC Microbiology data integrity to historical and current regulatory enforcement actions relating to Burkholderia cepecia complex.  Effectively recognizing and addressing these current trends is key to cGMP compliance.

“Current Trends in Pharmaceutical Microbiology” will provide an excellent opportunity for participants to acquire the knowledge and learn the skills necessary for managing these challenges.


 Read more and register here.



Monday, November 12, 2018

8:00 - 8:30 am

Registration and Full Breakfast Buffet

8:30 - 9:00 am

Welcome – Robert Westney

9:00 - 10:30 am

Utilizing an Organized Data Driven Approach to Investigate, Solve Problems, and Demonstrate Process Control – Matthew Paquette, Product Specialist, Charles River

10:30 - 11:00 am


11:00 am - 12:00 pm

Establishing Environmental Monitoring Alert and Action Levels: A Novel Case Study – Doug Schmidt, Director of Quality Control, Exela Pharma Sciences LLC

12:00 - 1:00 pm


1:00 - 2:00 pm

Burkholderia cepacia complex: Current Regulatory Trends – Bob Westney, Director of Quality and Operations, Cryologics Inc.

2:00 - 3:00 pm

Manufacturing Quality Product in an Aging Facility – Randy Hutt, Associate Director, Microbiological Services, Luitpold Pharmaceuticals

3:00 – 3:30 pm


3:30 - 5:00 pm

Microbial Monitoring of Potable Water and Waters for Pharmaceutical Purposes: Myths and Best Practices – Tony Cundell, Ph.D., Consulting Microbiologist

5:00 - 6:30 pm



Tuesday, November 13, 2018

8:00 - 8:30 am

Registration and Full Breakfast Buffet 

8:30 - 10:00 am

QC Microbiology: How Automation and Integration Enforce Data Integrity – Rob Lutskus, Global Product Delivery Manager – Informatics, Lonza

10:00 - 10:30 am


10:30 - 11:30 am

Use of the USP for Training, Standards, and Best Practices in Pharmaceutical Microbiology – Don Singer, Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, GlaxoSmithKline

11:30 am -12:30 pm


12:30 - 1:30 pm

Surviving the Microbiology Lab Audit - Tips from the Trenches – Rick Jakober, Vice President of Laboratory Services, Perritt Laboratories, Inc.

1:30 - 2:00 pm


2:00 - 3:00 pm

Identification Techniques of Environmental Isolates – Brian Beck, Ph.D., VP of Research and Development, Microbiologics Inc.

3:00 - 3:30 pm

Panel Discussion

·         Robert Westney

·         Matthew Paquette

·         Doug Schmidt

·         Tony Cundell

·         Randy Hutt

·         Rob Lutskus

·         Don Singer

·         Rick Jakober

·         Brian Beck


Conference Concludes


Moderator:  Mr. Robert Westney

Presentation Title: Burkholderia cepacia complex: Current Regulatory Trends

Abstract: This presentation will review the history surrounding the ever-increasing regulatory concern over Burkholderia cepacia complex (Bcc).  Bcc was highlighted by the U.S. Food and Drug Administration in 2011, in its publication “Burkholderia cepacia: This Decision Is Overdue”.  Following that, the FDA reiterated its concern over Bcc in its announcement last year.  Since their 2011 publication, increasing FDA scrutiny has resulted in many warning letters, product recalls and advisory updates.  We will review these events, and discuss strategies for mitigating Bcc contamination and avoiding regulatory scrutiny and enforcement.

Don Singer

Presentation Title: Use of the USP for Training, Standards, and Best Practices in Pharmaceutical Microbiology”

Abstract: Training has always been a key part of the strategy to developing microbiologists for their intended pharmaceutical roles and for developing a broad perspective for learning a microbiological body of knowledge.  In the past decade, USP has been updating chapters and developing informational resources for gaining better understanding in areas of microbiological Quality Control.  USP can be used not only as a source of standards, but also as a learning tool for microbiologists in sterile and non-sterile product organizations.

Tony Cundell, Ph. D.

Presentation Title: Microbial Monitoring of Potable Water and Waters for Pharmaceutical Purposes: Myths and Best Practices

Abstract:  This presentation will discuss the following areas:

Brief history of water monitoring

Grades of water used in the pharmaceutical industry

Methods used in the production of pharmaceutical grade waters

Regulatory expectations in terms of pharmaceutical grade water

Potable water monitoring – Heterotopic Plate Count, Total Coliforms and Fecal Coliforms

Purified water and water for injection monitoring – Traditional versus modern monitoring methods

Biofilm formation

Effect of media selection, incubation temperature, incubation time and method on microbial recoveries

Uses of potable water and pharmaceutical grade water in pharmaceutical manufacturing

Setting alert and action levels for water monitoring – why a new paradigm is needed

Investigations of action level excursions

Common misconceptions amongst pharmaceutical microbiologist, quality organizations and regulators


Doug Schmidt

Presentation Title: Establishing Environmental Monitoring Alert and Action Levels: A Novel Case Study

Abstract: This presentation will review a real-life case study describing the qualification of an environmental monitoring (EM) program for a sterile manufacturing facility.  It will review the specific risk-based strategies for site selection and sample types, encompassing component preparation, formulation, and filling (including lyophilization) of parenterals in a vial presentation. These strategies are applicable to a broad array of sterile manufacturing settings, including aseptic and terminal sterilized manufacturing processes and presentations in vials, IV bags, and pre-filled syringes. The presentation will include lessons learned from missteps in application of cleanroom classifications, discussion on transition from a paper-based trending system to an electronic based system, and will conclude with guidance on data analysis for the purpose of selecting sites to include in the routine EM program and establishing EM Alert and Action Levels.

Matthew Paquette

Presentation Title: Utilizing an Organized Data Driven Approach to Investigate, Solve Problems, and Demonstrate Process Control

Abstract: One of the first elements of any regulatory audit is to analyze and scrutinize a firm’s investigation reports as well as to review how a firm controls their manufacturing and laboratory processes.  Considering this knowledge, it is critically important for patient safety and quality compliance that investigations and how a firm demonstrates process control are done right the first time.  

A key component of any quality management system is the ability of that system to:

Solve problems with well-organized investigations that drive to root cause;

Make data driven decisions that improve process performance and eliminate the risk for human error;

Track and trend data to reduce variability and demonstrate process control.

This talk will present a simple approach to conducting manufacturing or laboratory investigations, using methodologies that have been proven by industry and that have been vetted by regulatory bodies.  The tools presented by this case study build a foundation for driving to root cause using tracking and trending, data, and sound scientific theory.  In this way, the industry can ensure patient safety and product quality by solving problems, reducing process variability, and demonstrating a state of complete manufacturing and laboratory process control.

Randy Hutt, Ph.D.

Presentation Title: Manufacturing Quality Product in an Aging Facility

Abstract: One must recognize that a facility is aging based on the building finishes, equipment downtime, and process or compliance concerns (measurable by metrics such as investigations, CAPAs and Change Controls).  Internal audits, gap assessments and other tools may be used to develop specific recommendations and CAPAs.  The key issue is whether the current facilities should be upgraded or whether you should consider a new facility.  A risk assessment could help in determining future actions.

The key question is whether you can still manufacture Quality Product in an older facility.  If you may just improve the current facility, consider:  Do you need inventory buildup before construction? Do you need regulatory submissions?  Consider the cost of quality if nothing is done: batch rejections, product shortages, possible recalls. Risk assessment for possible microbial ingress is a useful tool to develop CAPAs for upgrading an existing facility. This tool plus any gap analyses will help you decide if this is a possible remediation action, or if the only answer is to build a new facility.  Whatever the decided route, it is advisable to discuss your plans with regulatory agencies.  Written plans must include target dates and responsible personnel for each step.  A cross-functional team is critical to the success of such a project.

Rob Lutskus

Presentation Title: QC Microbiology: How Automation and Integration Enforce Data Integrity

Abstract: Manufacturing and QC personnel generate a significant amount of data, both on paper and electronically.   This data can be error prone and difficult to compile.  Integrating devices and systems will reduce error and allow data decisions to made quickly.

Rick Jakober

Presentation Title: Surviving the Microbiology Lab Audit: Tips from the Trenches

Abstract: If you’ve ever been on the receiving end of an audit of your microbiology lab, you know how stressful that situation can be, regardless if it’s the FDA, a client audit or even an internal company audit. This interactive talk will discuss our experiences with these types of audits, and will include things to do (and not to do!). We will discuss tips to prepare for your audit (especially unannounced ones), documents to share (and maybe not share), what to do and say during the audit, where auditors can and should not go and how to respond to audit findings. We will also discuss ways to help you avoid audit traps and how to address contentious findings.

Brian Beck, Ph.D.

Presentation Title: Identification Techniques of Environmental Isolates

Abstract: Environmental monitoring of cleanrooms and other controlled environments in pharmaceutical and healthcare manufacturing facilities may identify loss of contamination control during product processing. Facilities should develop a database for tracking and trending isolates, including location and levels for a baseline on their facilities microflora according to USP <1116>.  Identification and preservation of these isolates is critical to future corrective responses. Automated systems for microbial identification have been developed using phenotypic or genotypic methods and are supported with well authenticated strains from culture collections.  Multiple service providers combine these identification methods to provide a polyphasic identification of environmental isolates. This presentation will provide a summary of different identification methods, levels of identification and difficult scenarios to consider when identifying your environmental isolates.