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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
  • The Americas
  • 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

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

    10:15 a.m. – 11:00 a.m.
    Talk 1
    Andreas Kuhn, PhD, Senior Vice President & Head of RNA Biochemistry and Manufacturing, BioNTech

    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 Technologies
    Moderator: Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    12:30 p.m. – 1:00 p.m.
    Case Study - Qualification of a Fully Robotic Isolator for Aseptic Filling of Sterile Drugs
    Joseph McCall, SM (NRCM), Associate Director, QA Technical Services, ADMA Biologics

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

    1:30 p.m. – 1:45 p.m.
    Q&A

    B1: The Microbiologists Role
    Moderator: Christine Sherman, BA, Global Microbiology, Takeda

    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
    Industry Representative Invited

    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: Environmental Monitoring
    Moderator: Kim R. Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

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

    2:45 p.m. – 3:15 p.m.
    Scott Weiss, Director Industrial Microbiology - Sterility Assurance, Johnson & Johnson

    3:15 p.m. – 3:30 p.m.
    Q&A

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

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

    2:45 p.m. – 3:15 p.m.
    Industry Representative Invited

    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

    10:00 a.m. – 11:15 a.m.
    P2

    10:00 a.m. – 10:30 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.

    10:30 a.m. – 11:00 a.m.
    Industry Representative Invited

    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

    A3: Contamination Control
    Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

    12:15 p.m. – 12:45 p.m.
    Risk Assessment Approach to Cleanroom Contamination Control - Influencing Cleaning and Disinfection Standards
    Ecolab Life Sciences

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

    1:15 p.m. – 1:30 p.m.
    Q&A

    B3: Laboratory Operation and Inspectional Findings
    Moderator: Leslie A. Furr, MS, SM (NRCM), Associate Scientific Liaison, US Pharmacopeia

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

    12:45 p.m. – 1:15 p.m.
    Inspectional Trends/Findings
    U.S. FDA Representative Invited

    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: Automation
    Moderator: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence, Bristol-Myers Squibb

    2:15 p.m. – 2:45 p.m.
    Automated Environmental Monitoring: THE solution for the Next Decade
    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: Radiopharmaceuticals
    Moderator: Lynne A. Ensor, PhD, Vice President, Technical, PAREXEL International

    2:15 p.m. – 2:45 p.m.
    Radiopharmaceuticals: A Microbiologists Challenge
    Keira Anderson-King, Microbiology Quality Manager, ANSTO

    2:45 p.m. – 3:15 p.m.
    Radiopharmaceuticals
    U.S. FDA Representative Invited

    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

    10:00 a.m. – 11:15 a.m.
    P3


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

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

    A5: Aseptic Processing
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

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

    12:45 p.m. – 1:15 p.m.
    Aseptic
    U.S. FDA Representative Invited

    1:15 p.m. – 1:30 p.m.
    Q&A

    B5: Disinfection

    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 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
    Candace Y. Gomez-Broughton, PhD, Microbiologist, CDER, U.S. FDA
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA
    Erika A. Pfeiler, Supervisory Microbiologist, CDER, U.S. FDA
    U.S. FDA Representative Invited
    U.S. FDA Representative Invited

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

Highlighted Speakers

Linda C.L Boele
Linda C.L Boele
Kite Pharma EU
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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