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15th PDA Micro 1988x680

15th Annual PDA Global Conference on Pharmaceutical Microbiology

Keeping Microbiology in the Loop

Oct 19 - Oct 21, 2020
Eastern Standard Time | Online
  • Conference
  • Virtual
  • Online

Overview

The 15th Annual PDA Global Conference on Pharmaceutical Microbiology is going Virtual!

This Conference continues the ongoing tradition of addressing the opportunities and challenges, most relevant, to the future of microbiology in today’s global market. Join new and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, to share insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.

Take a look at the many opportunities that will shape the future of the pharmaceutical industry, such as how to best use non-compendial methods for microbial testing of new products, how to overcome challenges with aseptic processing, and what might be in store for the effective use of risk assessment and mitigation in product manufacturing, environmental monitoring, and microbial control. Additionally, the science of biotech microbiology and its impact on the industry in a dynamic fast paced global manufacturing environment will be addressed throughout the Conference.

The comprehensive program agenda will include presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. The Conference will also highlight the following hot topics:

  • Novel biotechnology processes, including cell and gene therapies
  • Globalization of aseptic processing
  • Common microbial deficiencies in regulatory filings and inspections
  • Contamination control case studies
  • Innovative technologies, products, and processes

There will be plenty of opportunities to listen to and directly interact with all the speakers, in addition to lively Q&A sessions that promise to stimulate the discussions and encourage attendee participation. Interactive breakfast sessions will feature small group discussions on topics important to the industry.

During the conference, PDA will host many poster presentations and an exhibition of leading bio/pharmaceutical companies that will showcase new technologies and trends for pharmaceutical microbiology strategies.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Monday, October 19

    10:00 a.m. – 11:30 a.m. | P1: Looping in mRNA-Based Therapies Brings Hope
    Moderator: MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

    During these unprecedented COVID-19 times we kick off the conference with our first plenary speaker who will explore the use of mRNA-based therapies for multiple applications. As the world searches for a long term solution to social isolation and face masks, this session describes how, at “light speed” in a GMP environment, one searches for the best candidate to address treatment of emerging diseases including the one responsible for the current worldwide pandemic. Understanding the criticality of experience in study design, ongoing collaboration with health authorities, identifying key partners and scale up considerations, all resulting in the rapid dosing of patients generating promising phase 1/phase 2 data bringing hope and the possibility of a change to the current state of the universe.

    10:00 a.m. – 10:15 a.m.
    Welcome from Program Planning Committee Co-Chairs

    10:15 a.m. – 11:00 a.m.
    mRNA-Based Therapeutics for Oncology and Viral Infections
    Andreas N. Kuhn, PhD, Senior Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH

    11:00 a.m. – 11:30 a.m.
    Q&A

    11:30 a.m. – 12:30 p.m.
    Virtual Exhibit Hall Open

    12:30 p.m. – 1:45 p.m.
    Concurrent Sessions

    A1: Aseptic Manufacturing Challenges, Mistakes, and Robotic Technologies
    Moderator: Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    There are many technologies to fill aseptic products in a traditional cleanroom RABS or isolator and common mistakes occur with the design and integration of these technologies. Morgan Polen will share his insights into some of these mistakes while Joseph McCall will provide a case study and his thoughts on the qualification of a fully robotic isolator for aseptic filling of sterile products.

    12:30 p.m. – 1:00 p.m.
    Common Mistakes in Cleanroom, RABS and Isolator Design and Integration
    Morgan Polen, Cleanroom, Particulate and Airflow Expert, Microrite, Inc

    1:00 p.m. – 1:30 p.m.
    Case Study - Qualification of a Fully Robotic Isolator for Aseptic Filling of Sterile Drugs
    Joseph E. McCall, SM (NRCM), Associate Director, QA Technical Services, ADMA Biologics, Inc

    1:30 p.m. – 1:45 p.m.
    Q&A

    B1: The Microbiologist's Role – A Day in the Life
    Moderator: Christine Sherman, BA, Global Microbiology, Takeda

    Have you ever wondered what a Microbiologist contributes to well executed Container Closure studies or Contamination investigations? Two Microbiologist SMEs will share their expertise in these fields. Don Singer will provide his insights on the technical requirements for container closure integrity. Christopher Murdock will provide his thoughts on one of the more challenging events in a Microbiologist’s career, providing support for a contamination investigation.

    12:30 p.m. – 1:00 p.m.
    The Microbiologist's Role in Container Closure Integrity - USP/PDA Technical Guidance
    Donald C. Singer, MA, (NRCM), Senior Microbiology Technical Consultant, N.A., Ecolab Life Sciences

    1:00 p.m. – 1:30 p.m.
    The Microbiologist’s Role in Microbiological Deviation Investigation
    Christopher A. Murdock, Senior Director, Esperion Therapeutics

    1:30 p.m. – 1:45 p.m.
    Q&A

    1:45 p.m. – 2:15 p.m.
    Virtual Exhibit Hall Open

    2:15 p.m. – 3:30 p.m.
    Concurrent Sessions

    A2: Effective Environmental Monitoring Programs using One-Medium/Single-Incubation Conditions
    Moderator: Kim Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    The Environmental Monitoring (EM) session will describe the effectiveness of optimal medium/incubation conditions for viable EM samples based on literature search, empirical data and regulatory requirements. The first presentation describes the studies performed to evaluate the capability of a one-medium / single-incubation conditions for detecting microbial diversity in EM samples. The second presentation will provide an update on PDA Environmental Task Force’s efforts to evaluate the effectiveness of a one-medium/one-incubation condition for optimal detection of bacteria and fungi.

    2:15 p.m. – 2:45 p.m.
    Selection of Incubation Conditions for Environmental Monitoring Samples at TCF04Kite Pharma EU
    Linda C.L Boele, BSc, Senior Manager - QC Microbiology, Kite Pharma EU
    Arabela X. Cuirolo, PhD, QC Specialist III – Microbiology, Kite Pharma EU B.V.

    2:45 p.m. – 3:15 p.m.
    Effectiveness of One Media/One Incubation Condition for Functional Environmental Monitoring Program: An Update
    Scott E. Weiss, BS, Director, Industrial Microbiology, Johnson & Johnson

    3:15 p.m. – 3:30 p.m.
    Q&A

    B2: Monocyte Activation Test – Teenage Years are Over
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    It has been 10 years since the Monocyte Activation Test became a compendial test in the EU. MAT has the potential to replace Rabbit Pyrogen Testing but is still awaiting its global acceptance. Two industry experts share their experiences and provide a user perspective of MAT.

    2:15 p.m. – 2:45 p.m.
    The Monocyte Activation Test – A Reliable Alternative to the Rabbit Pyrogen Test?
    Johannes M. Reich, MA, PhD, Managing Director, Microcoat Biotechnologie GmbH
    Ruth Roeder, PhD, Devision Manager, Microcoat Biotechnologie GmbH

    2:45 p.m. – 3:15 p.m.
    Considerations for Development of the Monocyte Activation Test as an In-Vitro Replacement for the Rabbit Pyrogen Test
    Jessica A. Campbell, PhD, Principal Scientist, Pfizer

    3:15 p.m. – 3:30 p.m.
    Q&A

    3:30 p.m. – 4:00 p.m.
    Virtual Poster Hall Open

  • Tuesday, October 20

    8:30 a.m. – 9:45 a.m. | Breakfast Session: Contamination Control Strategy Tech Report
    Moderator: Christine Sherman, BA, Global Microbiology, Takeda

    PDA has SMEs working on a draft TR to provide guidance on preparing a Contamination Control Strategy and risk assessment for your manufacturing process. This is an excellent opportunity to chat with the authors and get a preview of the process and content for a thorough and well-documented strategy risk assessment.

    8:30 a.m. – 9:45 a.m.
    Panel Discussion
    Reyes Candau-Chacon, PhD, Quality Assessment Lead, CDER, U.S. FDA
    Cheryl E. Essex, MS, Head of Microbiological Control, Sanofi
    Jeanne Mateffy, Amgen Inc.
    Ed C. Tidswell, PhD, BSc, Executive Director QA, Merck & Co., Inc.

    10:00 a.m. – 11:15 a.m. | P2: The Pathway to the First FDA-Approved Ebola Vaccine
    Moderator: Yeissa Chabrier-Rosello, PhD, Microbiologist, CDER, U.S. FDA

    The Ebola virus disease (EVD) was discovered in 1976 in the Democratic Republic of the Congo (formerly Zaire). EVD is a rare and often fatal illness characterized by causing a hemorrhagic disease in those infected, leading to a 50-90% fatality rate. Since its discovery over 10 outbreaks have occurred, mostly in Central and West Africa, with the most recent occurring in June 2020. These outbreaks were declared public health emergencies by the World Health Organization. The declaration of a public health emergency for EVD led to the formation of global partnerships and collaborations among the private sector, regulatory agencies and world governments to embark on the quest of finding new drugs, therapies and treatments to combat this deadly viral disease. This session will tell the story of the development and final approval of the first FDA-approved vaccine for the prevention of Ebola virus disease (ERVEBO® by Merck) in 2019, from a pharmaceutical microbiology perspective.

    10:00 a.m. – 10:45 a.m.
    Opportunities in Pharmaceutical Microbiology: Use of Recombinant Vesicular Stomatitis Virus Genetically Modified with the Ebola Virus Surface Glycoprotein to Combat Ebola Virus Infection
    William Lapps, Jr., PhD, Director/Liaison, Vaccines & Infectious Diseases, Global Regulatory Affairs, Merck & Co., Inc.

    10:45 a.m. – 11:15 a.m.
    Q&A


    11:15 a.m. – 12:15 p.m.
    Virtual Exhibit Hall Open

    12:15 p.m. – 1:30 p.m.
    Concurrent Sessions

    A3: The Role of Quality Risk Assessment in the Development of a Contamination Control Strategy
    Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

    Contamination control is a challenging and significant issue for the pharmaceutical industry. It requires steps to be taken to identify, assess and evaluate controls that will minimize risk of the sources of microbial and particulate contamination. The importance of quality risk management approaches has been recognized in the pharmaceutical industry and has become a valuable component supporting contamination control. Updates to Annex 1 calls for the implementation of a Contamination Control Strategy across the facility to define all control points and assess and monitor the effectiveness of all the controls. The utilization of quality risk management approaches can be applied for the development of an end to end contamination control strategy. This section will include a risk assessment approach to contamination control for cleaning and disinfection and a case study on the development of a contamination control strategy using the QRA FMEA tool.

    12:15 p.m. – 12:45 p.m.
    Risk Assessment Approach to Cleanroom Contamination Control - Influencing Cleaning and Disinfection Standards
    Helen Gates, BSc, Global Technical Consultant, Ecolab Life Sciences

    12:45 p.m. – 1:15 p.m.
    Case Study: Leveraging a FMEA to Create a Contamination Control Strategy
    Karen S. Ginsbury. BPharm, MSc, Consultant, PCI Pharmaceutical Consulting Israel

    1:15 p.m. – 1:30 p.m.
    Q&A

    B3: Microbiology Laboratory Data and Inspection Trends
    Moderator: Leslie A. Furr, MS, SM (NRCM), Associate Scientific Liaison, US Pharmacopeia

    Microbiology data collection for manual methods presents unique challenges for ensuring data integrity. This session will focus on points to consider for implementing second analyst verification in a cGMP facility. This session will also include current FDA inspection findings and trends that will highlight recent industry quality challenges.

    12:15 p.m. – 12:45 p.m.
    Points to Consider When Implementing Second Operator Verification of Microbiological Laboratory Data
    Paula J. Peacos, MS, Senior Consultant, ValSource, Inc.

    12:45 p.m. – 1:15 p.m.
    Current Microbiological Inspectional Findings and Trend Analysis: A Pharmaceutical Perspective
    Simone Pitts, Consumer Safety Officer, ORA, U.S. FDA

    1:15 p.m. – 1:30 p.m.
    Q&A

    1:30 p.m. – 2:15 p.m.
    Virtual Exhibit Hall Open

    2:15 p.m. – 3:30 p.m.
    Concurrent Sessions

    A4: Automated Microbial Test Technologies for Water and EM: Are you in the Loop?
    Moderator: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence, Bristol-Myers Squibb

    Automating assays in the area of environmental monitoring and water testing in a pharmaceutical manufacturing facility poses great advantages in efficiency, data integrity and ability to react faster to atypical events, ultimately leading to better control of the facility. This session takes us through two case studies of the use of automated technologies for EM and water testing and will provide the audience with a chance to hear firsthand from users of the technologies.

    2:15 p.m. – 2:45 p.m.
    Automated Environmental Monitoring: THE Solution for the Next Decade
    Niels JF Visschers, Specialist Operations, MSD
    Maria R. Flores, PhD, Scientific Technical Specialist, MSD

    2:45 p.m. – 3:15 p.m.
    From Fiction to Reality: Lessons Learned from 8 Months of Continuous Water Monitoring Using Bio-Fluorescent Particle Counter
    Joanny Salvas, Manager, Pfizer

    3:15 p.m. – 3:30 p.m.
    Q&A

    B4: Microbiological Attributes and Testing Considerations for Radiopharmaceuticals
    Moderator: Lynne A. Ensor, PhD, Vice President, Technical, PAREXEL International

    This session will focus on the challenges encountered from a microbiology perspective when developing, manufacturing, and/or testing radiopharmaceuticals. Implementable solutions for meeting potentially challenging regulatory expectations for the microbiological attributes of radiopharmaceuticals, as well as maintaining compliance with radiation safety standards while doing so, will be discussed.

    2:15 p.m. – 2:45 p.m.
    Radiopharmaceuticals: A Microbiologists Challenge
    Keira F. Anderson-King, Sterility Assurance Specialist ANZ, Baxter

    2:45 p.m. – 3:15 p.m.
    Radiopharmaceuticals
    Laura R. Wasil, Microbiologist, CDER, U.S. FDA

    3:15 p.m. – 3:30 p.m.
    Q&A

    3:30 p.m. – 4:00 p.m.
    Virtual Poster Hall Open

  • Wednesday, October 21

    8:30 a.m. – 9:45 a.m. | Breakfast Session: Mold Contamination and Remediation - The Moldy Nightmare
    Moderator: Friedrich von Wintzingerode, PhD,
    QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    Molds and fungi are a mystery even to experienced microbiologists due to their huge diversity, complex life cycles and confusing taxonomy. Ziva Abraham, one of the industry leading mycologists is presenting on mold contaminations and remediation, as well as fungal taxonomy. Her case studies and lessons learned reflect her +40 years of experience within this field.

    8:30 a.m. – 9:00 a.m.
    Ziva Abraham, PhD, CEO, Microrite, Inc

    9:00 a.m. – 9:45 a.m.
    Q&A

    10:00 a.m. – 11:15 a.m. | P3: Pharmacy Compounding and Radiopharmaceutical Processing
    Moderator: Kim R. Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    Compounding and Radiopharmaceutical USP guidance continues to evolve and provide further instruction to those in the industry who produce sterile drugs at Pharmacy locations. This session will discuss FDA oversight of pharmacy compounding, including a new FDA initiative with stakeholders to collaboratively improve the quality of compounded drugs, and highlight the new USP chapter <825> requirements for preparation, compounding, dispensing, and repackaging of radiopharmaceuticals.

    10:00 a.m. – 10:30 a.m.
    FDA Oversight of Pharmacy Compounding-An Update
    John W. Metcalfe, PhD,
    Master Microbiology Reviewer, CDER, U.S. FDA

    10:30 a.m. – 11:00 a.m.
    USP General Chapter <825> Overview
    Paul B. Mahan, RPh, BCNP,
    Senior Regulatory Affairs Specialist, PETNET Solutions | A Siemens Company

    11:00 a.m. – 11:15 a.m.
    Q&A

     


    11:15 a.m. – 12:15 p.m.
    Virtual Exhibit Hall Open

    12:15 p.m. – 1:30 p.m.
    Concurrent Sessions

    A5: Sterile Process Validation: Possibilities and Insights
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    This session will cover key aspects of sterile processing of pharmaceutical products. In the first half, the speaker will discuss the use of parametric release as a possible approach for sterile injectable products and rigorous controls that would be required for such a process to be implemented successfully. The second presentation will provide insight from a regulatory perspective, wherein the speaker will discuss commonly issued incomplete comments for sterile process validation, as well as discuss the expectations and importance of overall process understanding. The second presentation will also touch upon deviations and inspectional issues.

    12:15 p.m. – 12:45 p.m.
    AP(+): Post-Aseptic Processing Terminal Treatment and its Potential Use for Parametric Release
    Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.

    12:45 p.m. – 1:15 p.m.
    Case Studies for Common Incomplete Issues and Alternate Approaches for Sterile Process Validation
    Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA

    1:15 p.m. – 1:30 p.m.
    Q&A

    B5: An Exploration of Decontamination and Sanitization Agents
    Moderator: Candace Y. Gomez-Broughton, PhD, Supervisory Microbiologist, CDER, U.S. FDA

    This session will focus on strategies used for surface decontamination and cleanroom sanitization. The first speaker will give insights on the use of vapor phase hydrogen peroxide (VPHP). The speaker will discuss typical process parameters for VPHP decontamination and ways to optimize the program. The second presentation will feature a case study on the selection of an effective cleanroom sanitization regimen. Criteria used to select the appropriate cleaning agent will be discussed.

    12:15 p.m. – 12:45 p.m.
    Debunking the Myths of Vapor Phase Hydrogen Peroxide Decontamination
    Claire F. Briglia, BS, Consultant, Vedere Solutions

    12:45 p.m. – 1:15 p.m.
    Evaluation of a Quaternary Ammonium Ready to Use (RTU) Disinfectant and Hydrogen Peroxide/Peracetic Ready to Use (RTU) Combination Sanitization Regimen for Cleanroom Start-Up
    Thomas M. Walker, BS, Senior Quality Assurance Manager, Novartis Pharmaceuticals
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation

    1:15 p.m. – 1:30 p.m.
    Q&A

    1:30 p.m. – 2:15 p.m.
    Virtual Exhibit Hall Open

    2:15 p.m. – 3:45 p.m.
    P4: Ask the Regulators
    Moderator: John W. Metcalfe, PhD,
    Master Microbiology Reviewer, CDER, U.S. FDA

    2:15 p.m. – 3:30 p.m.
    Panel Discussion
    Reyes Candau-Chacon, PhD, Quality Assessment Lead, CDER, U.S. FDA
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA
    Candace Y. Gomez-Broughton, PhD, Microbiologist, CDER, U.S. FDA
    Erika A. Pfeiler, Supervisory Microbiologist, CDER, U.S. FDA
    J. Kevin Rice, PhD, Review Chemist, CVM, U.S. FDA

    3:30 p.m. – 3:45 p.m.
    Closing Remarks

Highlighted Speakers

Renée S. Blosser
Renée S. Blosser
U.S. FDA
Rick L. Friedman
Rick L. Friedman
U.S. FDA
Andreas N. Kuhn
Andreas N. Kuhn
BioNTech RNA Pharmaceuticals GmbH
William Lapps, Jr.
William Lapps, Jr.
Merck & Co., Inc.
Paula Peacos
Paula Peacos
ValSource, Inc.
Erika A. Pfeiler
Erika A. Pfeiler
U.S. FDA
Morgan Polen
Morgan Polen
Microrite, Inc.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences

Learning Objectives

At the completion of this conference, participants will be able to:

  1. Broaden their knowledge in many areas of Microbiology by listening to the leaders in the industry in such topics as novel processes, products, and technologies
  2. Deepen their understanding of topics such as microbial risk, microbial control, and endotoxin testing
  3. Identify current and future trends in Microbiology
  4. Implement improvements at their own facilities using information gained through expert presentations and networking opportunities
  5. Identify regulatory and pharmacopeial expectations
  6. Understand global aspects of microbiology and aseptic processing
  7. Summarize best practices for utilizing EM data to control processes

Who Should Attend

Departments
  • Microbiology
  • Compliance
  • Engineering
  • Manufacturing
  • QA/QC
  • Regulatory Affairs
  • Research and Development
  • Validation

Level of Expertise
  • Executives
  • Managements
  • Scientists/Technicians

Job Function
  • Scientist/Technician
  • Research
  • Bench Personnel
  • Pharmaceutical Industry Consultants
  • Regulatory Affairs
  • Health Authorities
  • Analyst

Registration Fees

Register Now
Registration Type Price
Virtual Conference
Member $1,756
Non-member $2,035
Young Professional Member $878
Gov’t/Health Auth./Academic Member $560
Gov’t/Health Auth./Academic Non-member $640
Student Member $224
Student Non-member $248

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