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2022 Micro Conference

2022 PDA Pharmaceutical Microbiology Conference

Oct 10 - Oct 12, 2022
Washington, DC

Leading through Science: A Monumental Undertaking

  • Conference
  • The Americas

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Program Highlights

The program agenda is now available!

Overview

Welcome to the 2022 PDA Pharmaceutical Microbiology Conference!

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
  • Learned lessons in a post COVID world-perspective from industry and regulators

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, 10 OCTOBER

    07:00 – 17:30 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    08:15 – 10:00 | P1:  
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    08:15 | Welcome from PDA President
    Richard Johnson, President, PDA

    08:30 | Welcome from Program Planning Committee Co-Chairs
    Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio
    Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    08:45 | Missing Microbes: How the Overuse of Antitbiotics Is Fueling Our Modern Plagues
    Martin Blaser, MD, Director, Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 – 12:00 | Concurrent Sessions

    A1 
    Moderator: Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    10:30 | PDA Technical Report #88 - Microbial Data Deviations in the Pharmaceutical Industry
    Kim Sobien, MBA, MSAT Contamination Control Lead, GSK

    10:55 | Improvement of Contamination Control Practices Using Investigational Testing
    Steve Wieczorek, BS, Director of Quality Control, Resilience, Inc

    11:15 | Regulatory Perspective
    Regulatory Representative Invited

    11:40 | Q&A

    B1
    Moderator: MaryEllen E. Usarzewicz, MS, Director, QC Microbiology, Bristol-Myers Squibb

    10:30 | Remediation of Contaminated Protein A resin: Guidance for Operational Teams
    Angelica Welch, BS, MSAT Consultant, ValSource

    10:55 | What if you Could do your Media Fill Inspection in a Couple of Hours? A Case Study for the Application of Inspection Technology to Micro Testing
    Joanny Salvas, Senior Manager, Pfizer

    11:15 | Systematically Safeguarding Container Closure System for Controlling Microbial Contamination
    Qingyu Zeng, PhD, Fellow & Technical Director, West Pharmaceutical Services, Inc.
    Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC

    11:40 | Q&A

    12:00 – 13:00 | Grand Opening of the Exhibit Hall and Networking Lunch

    13:30 – 15:00 | Concurrent Sessions

    A2
    Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio

    13:30 | The Five Micron Particle Dilemma, Common Mistakes and Misunderstandings in Non-Viable Particle Counting (Cleanroom Classification and Monitoring)
    Morgan Polen, Cleanroom, Air Flow and Particle Contamination Expert, Microrite, inc.

    13:55 | The Evaluation of a Ready to Use Combination Disinfection Regimen to Support a Contamination Control Strategy
    Thomas M. Walker, BS, Senior Quality Assurance Manager, Novartis Pharmaceuticals

    14:15 | Cleanroom Qualification vs. Monitoring: Differences in Regulatory Expectations
    Gilberto Dalmaso, PhD, Technical Science Director for Europe and Asia, Veltek Associates Inc.

    14:40 | Q&A

    B2
    Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK Vaccines

    13:30 | Development of Improved Mold Recovery for Rapid Sterility Testing Using an Automated Culture System
    Dorien Ruegebrink, Microbiology Specialist, MSD  
    Lori L. Daane, PhD, Sr Director of Scientific Affairs, bioMerieux, Inc

    13:55 | Analysis of Short-Term Variations of Microbiological Loads in Purified Water as a Valuable Tool for Root Cause Investigations: Comparison with Culture-Based Methods
    Tamara Garcia-Armisen, Sterility Assurance Manager, GSK

    14:15 | Key Lessons Learned from Ongoing Implementation of Two Automated EM Systems within Merck
    Jessica E. Long, Microbiology Specialist, Merk & Co., Inc. 
    Niels JF Visschers, Senior Specialist Microbiology, MSD

    14:40 | Q&A

    15:00 – 15:45 | Networking Break in the Exhibit Hall

    15:45 – 17:15 | Concurrent Sessions

    A3
    Moderator: Frederic B. Ayers, Advisor - TS/MS Sterility Assurance Technology, Eli Lilly and Company

    15:45 | In Pursuit of an Ideal Sterility Test: A novel Approach-Based on Raman Spectroscopy and Multivariate Analysis
    Ellen Brunbech, MSc, Principal Scientist, Novo Nordisk A/S  
    Ruben A. Grosso, PhD, Postdoc, University of Southern Denmark

    16:10 | Parametric Release for Products Terminally Sterilized with Moist Heat: A Call to Action
    Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

    16:40 | Q&A with Additional Panelist
    Mike J. Sadowski, Lead Scientist, Baxter

    B3
    Moderator: Jason L. Willett, Midwest Manager, Veltek Associates, Inc.

    15:45 | Key Elements to consider for a successful Cleanroom Cleaning and Disinfection Program
    James N. Polarine, Jr., MA, Senior Technical Service Manager, Steris Corporation Life Science Technical Service  

    16:05 | Latest Updates on Reviewed Annex 1 and How to Move Ahead Towards its Compliance
    Rafael Beaus, Global Consultancy Manager, Azbil Telstar Technologies SL

    16:25 | Mold Recovery in Grade A: What does Investigation Entail?
    Gurpreet Ganda, Senior Manager, Roche  

    16:45 | Q&A

    17:15 – 18:30 | Networking Reception in the Exhibit Hall

  • TUESDAY, 11 OCTOBER

    07:00 – 17:30 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:15 – 08:15 | Breakfast Session

    08:3010:00 | P2
    Moderator: Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

    08:30 | Rajesh K. Gupta, PhD, President & Principal Consultant, Biologics Quality & Regulatory Consultants, LLC

    09:30 | Q&A

    10:00 – 10:45 | Networking Break in the Exhibit Hall

    10:45 – 12:15 |Concurrent Sessions

    A4
    Moderator: Dan J. Bice, Associate Director Quality Control Operations, Adaptimmune

    10:45 | Ways to Evaluate Environmental Monitoring Data as part of a Robust Contamination Control Strategy
    Frederic B. Ayers, Advisor - TS/MS Sterility Assurance Technology, Eli Lilly and Company

    11:05 | Changes in the new revision to PDA Technical Report #13, Fundamentals of an Environmental Monitoring Program
    Kurt Jaecques, Global Aseptic Technologies Lead Monitoring & Control, GSK Vaccines
    Marc Glogovsky, Business Unit Manager/Senior Consultant – Microbiology, Valsource

    11:25 | Q&A

    B4
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy),Genentech Inc

    10:45 | Assessment of Recombinant Factor C Enzyme Critical Quality Attributes and Impact on Assay Performance
    Sarah Johnson, Senior Biologist, CDER, U.S. FDA

    11:05 | Three years of MAT Proficiency Test Program
    Maria Gajewi, Group Leader Endotoxin Services, Microcoat Biotechnologie GmbH

    11:25 | The Assessment, Challenges, and Benefits of Implementing an Alternative Endotoxin Method with the use of rFactor C
    Emily Murphy, Senior Associate Scientist, Pfizer

    11:50 | Q&A

    12:15 – 13:45 | Networking Lunch in the Exhibit Hall

    13:45 – 15:15 | Concurrent Sessions

    A5
    Moderator: Lori L. Daane, PhD, Sr Director of Scientific Affairs, bioMerieux, Inc

    13:45 | Case Studies on Burkholderia cepacia complex (BCC) Investigations and Remediation
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    14:15 | Objectionable Microorganisms-A Challenge or a Dilemma
    Ziva Abraham, CEO, Microrite, Inc.

    14:45 | Q&A

    B5
    Moderator: Lynne A. Ensor, PhD, Senior Vice President & Head of Regulatory Consulting Services Global Compliance, PAREXEL International

    13:45 | Experiences and Practical Concepts for using Enzymatic Indicators in vH2O2 Bio-Decontamination Cycles: Advantages and Considerations of a New Technology  
    Holger Kranenburg, PhD, Senior Scientist GMP Compliance, Franz Ziel GmbH  
    Yemi Babatola, BS, MS, Principal Engineer, Amgen Inc.

    14:05 | Enzyme Indicators: A Paradigm Shift in H2O2 Cycle Development and Qualification; Case Studies, Applications, and Forward Thinking from a Pharma Working Group
    Terrence Hollis, Sr. Manager, Global Technology and Engineering, Pfizer  
    Kate M. Marshall, Global Projects Manager, Protak Scientific  

    14:30 | Isolator and Cleanroom Optimisation: Case Study on Inter-Related Dependencies and their Impact on Successful Isolator Bio-Decontamination  
    Milind Rokade, BE, M.Eng.Sc, PGDM, Subject Matter Expert, ProSys Group

    14:50 | Q&A

    15:15 – 16:00 | Networking Break in the Exhibit Hall

    16:00 – 17:30 | Concurrent Sessions

    A6
    Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

    16:00 | Repurposing a Sterility Test Isolator for Aseptic Processing in a Controlled Area
    Brian C. Patterson, Sr. Principal Scientist, Alcon Research, LLC

    16:20 | Pragmatic Approach for Facility Disinfectant Validation, 2022: Negotiating the Standards for Biologics, ATMPs, and Small Molecule Manufacturing
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences
    Harolyn Clow, MS, SM (NRM), Manager, Pharmaceutical Microbiology, Eurofins Biopharma

    16:45 | Microbiological Quality Level: A Different Way to Measure Sterility Assurance and Product Quality
    Stephen E. Langille, Microbiology Consultant, Valsource

    17:10 | Q&A

    B6
    Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

    16:00 | Implementing Membrane-Based Water for Injection Production  
    Joseph Manfredi, President/CEO, GMP Systems, Inc.  
    Michael R. Pacek, PE, Eastern Regional Manager, Stilmas Americas

    16:25 | Using Pulsed Light Technology to Enhance Sterility Assurance in a Clinical Scale Isolator-Based Sterile Filling Line
    Shawn D. Kinney, PhD, CEO/President, Berkshire Sterile Manufacturing  
    Lindsey Lungren, MS, Manager of QC Microbiology, Berkshire Sterile Manufacturing  

    16:50 | Validation of a Mitigation Strategy using a rFC-Based Method to Overcome LER  
    Michael Kracklauer, Manager Endotoxin Services, Microcoat Biotechnologie GmbH

    17:10 | Q&A

  • WEDNESDAY, 12 OCTOBER

    07:00 – 12:00 | Registration Open

    07:00 – 08:45 | Continental Breakfast

    07:15 – 08:30 | Breakfast Session
    Moderator: Josh E. Eaton, MS, Assistant Director, Scientific Affairs, PDA

    07:15 | Points to Consider for Microbiological Considerations for ATMPs
    Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    07:35 | Contamination Control Strategy
    Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    07:55 | Q&A

    08:45 – 10:00 | P3
    Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio

    08:45 | Erica L. Carpenter, MBA, PhD, Research Assistant Professor of Medicine, Perelman School of Medicine

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 – 12:15 | P4: Ask the Regulators
    Moderators: John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA and Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    10:30 | Panel Discussion
    CDR Donald B. Ertel, MS, MT(ASCP), Regulatory Officer, CBER, U.S. FDA
    CDER Representative Invited
    CVM Representative Invited
    ORA Representative Invited

    12:00 | Closing Remarks


Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Martin Blaser
Martin Blaser
Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University
Ellen Brunbech
Ellen Brunbech
Novo Nordisk A/S
Gilberto Dalmaso
Gilberto Dalmaso
Veltek Associates Inc.
Joseph Manfredi
Joseph Manfredi
GMP Systems, Inc.
Morgan Polen
Morgan Polen
Microrite, Inc.
Joanny Salvas
Joanny Salvas
Pfizer Inc.
Christine Sherman
Christine Sherman
Takeda

Additional Information

  • Learning Objectives

    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
    8. Apply some of the lessons learned by the pharmaceutical industry and regulators in a post COVID time
  • Who Should Attend
    Departments
    • Microbiology
    • Compliance
    • Engineering
    • Laboratory
    • Manufacturing
    • Product Development
    • QA/QC
    • Development
    • Regulatory Affairs
    • Research and Development
    • Validation
    Level of Expertise
    • Executives
    • Management
    • Scientist/Technicians
    Job Function
    • Scientist/Technicians
    • Research
    • Analyst
    • Bench Personnel
    • Pharmaceutical Industry Consultants
    • Regulatory Affairs
    • Health Authorities

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Grand Hyatt Washington

1000 H Street NW
Washington, DC
Phone: +1 (202) 582-1234

Make a Reservation
Grand Hyatt Washington
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $309 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 9 September 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    With a pristine location in the heart of Washington D.C. neighborhood, just steps away from downtown, our hotel ensures that you're never far from where you're looking to go. Explore from Grand Hyatt Washington, conveniently connected to the Metro Center train station from our lobby, allowing you to travel the red, orange, silver, and blue lines with ease to the city's beloved destinations and neighborhoods. See all of D.C.'s top sights from our front doors.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 4.2 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27 miles away, and Baltimore-Washington International Airport (BWI), 32 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001. Parking is available at the following rates: $45 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

The Hotel lobby is connected to the Metro Center Metro Station. Metro fare from Reagan National Airport (DCA) is approximately $2.30 (one-way). To plan your trip please visit www.WMATA.com.

Directions

Registration Fees

Regular Price
Registration Type Before 14 August After 14 August
Member $1,895 $2,395
Non-Member $2,195 $2,695
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,195 $1,195

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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