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2021 PDA Pharmaceutical Microbiology Conference

Oct 04 - Oct 06, 2021
Washington, DC

Microbiology is Evolving: Rising to the Challenge

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  • The Americas

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Welcome to the 2021 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.


  • Day 1
  • Day 2
  • Day 3
  • Monday, 4 October

    08:00 – 10:00 | Registration

    10:00 – 11:30 | P1 
    Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

    10:00 | Welcome from Program Planning Committee Co-Chairs
    Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA
    Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio

    10:15 | Review of Emergency use for Covid-19
    Sudhakar Agnihothram, Biologist, CBER,U.S. FDA

    11:00 | Q&A Panel
    Rakesh Pandey, PhD, Chief, Regulatory Review Branch-2, CBER, U.S. FDA

    11:45 – 13:00 | Lunch, Exhibit Hall, Poster Presentations, and Exhibitor Tech Talks

    13:00 – 14:30 | Concurrent Sessions

    A1: Rapid Microbiological Methods: Barriers and Success Stories 
    Moderator: Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

    Rapid Microbiological Methods (RMM) continue to advance at all forefronts, including general research, food quality, and pharmaceutical applications. RMM gives output with increased precision and sensitivity in short timeframe when compared to traditional methods that may take days or even weeks to deliver outcomes. However, RMMs do have a set of barriers for fast development and widespread use at the same time. This session will share presentations addressing RMM implementation and regulatory acceptance issues, sharing success over validation difficulties and technical complexities, onboarding new products, and transferring methods for new developmental products.

    13:00 | Back to the Future: Where are the Rapid Methods?
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    13:25 | Implementing a Rapid Sterility Method: How we Went from Bold Idea to Completed Project at Lightspeed
    Joanny Salvas, Senior Manager, Pfizer

    13:45 | Rapid Methods – The Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing
    Miriam Guest, Associate Principal Scientist, AstraZeneca

    14:10 | Q&A Panel

    B1: Pyrogen Testing: Automation Case Studies and Improved Safety Testing
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    Automated endotoxin testing and the monocyte activation test (MAT) are hot topics in the field of pyrogen testing. Two industry case studies demonstrate the benefits of automated LAL and rFC testing for QC laboratories. A third presentation underlines the potentiated risk to patient safety associated with the contamination of mixed pyrogens which at present largely go undetected, and MAT’s standing as the solution.

    13:00 | Holy Crab! A Simple, Automated Sample-to-Answer Recombinant Factor C Assay for Bacterial Endotoxins
    Jay Bolden, Lilly
    Cindy M. Heath, Senior Research Scientist - Automation, Eli Lilly

    13:25 | MAT: Understanding and Mitigating Patient Safety Risks due to Synergistic Effects of Mixed Pyrogens
    Shabnam Solati, MS, CEO, CTL-MAT

    13:45 | Implementing the QC Lab of the Future Today: Automating Endotoxin Testing for Water and Buffer Samples
    Aude J. Smeets, PhD, Analytical Technical Expert (Automation Field), GSK

    14:05 | Q&A Panel

    14:30 – 15:30 | Exhibit Hall, Poster Presentations, and Exhibitor Tech Talks

    15:30 – 17:00 | Concurrent Sessions

    A2: Developing and Managing an Effective Contamination Control Strategy
    Moderator: Kim R. Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    Many manufacturers have already developed multiple elements of a contamination control strategy (CCS), and still wrestle with tying them together in a single holistic program with a life-cycle approach. This session delves into best practices and case studies for defining, implementing, and sustaining successful contamination control strategies.

    15:30 | Strengthening the 'c' for Contamination Control - An Approach for Continuous Improvement
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    15:50 | Robust Contamination Control Strategies using Quality Risk Management and Quality System
    Stephen Langille, PhD, Senior Microbiology Consultant, ValSource Inc.
    Danica J. Brown, QRM Consultant, ValSource Inc.

    16:15 | Implementation of Contamination Control Strategy Across the Facility in Novo Nordisk A/S
    Jette Christensen, MSc, Scientific Director, Novo Nordisk A/S

    16:40 | Q&A Panel

    B2: Rising to the Challenge of Rapid Microbial Methods and Innovation: Industry Applications
    Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GlaxoSmithKline Vaccines

    Several rapid methods do not require microbial growth prior to detection or enumeration and, as such, the time to result can be close to real-time. Rapid methods that achieve these results include flow and solid-phase cytometry and biofluorescence detection of microorganisms in air. Although RMM is becoming more and more convenient, performant and accepted by regulatory bodies, some hesitation still exists to replace standard methods. Within this session, two case studies and one practical application will be presented that might help the industry to rise to this challenge.

    15:30 | Case Study using Alternative Rapid Microbial Method Scan RDI to Release Broad Spectrum Antivirals
    Omkar Baburao Patil, MSc Microbiology, Associate Director-Microbiology, Cipla Limited, Goa
    Ranjana B. Pathak, BSc, MBA, DHA, President - Global Quality, Medical Affairs & Pharmacovigilance, Cipla Limited

    16:00 | Implementation of Biofluorescence Particle Counters to Replace Traditional EM Methods
    Thais Vilgren, MSc, Principal Scientist, Global Lead Aseptic Processing, Novo Nordisk

    16:20 | Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting Technology
    Dawn M. Watson, Director, Microbial Control, Merck & Co., Inc.

    16:40 | Q&A Panel

    17:00 – 18:00 | Reception

  • Tuesday, 5 October

    07:30 – 08:30 | Registration

    08:30 – 09:45 | Understanding Regulatory Expectations and Strategies to Achieve them for Pharmacy Compounding and Virtual Facility Inspections
    Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

    This session will focus on providing useful information related to understanding and addressing regulatory expectations for CMC and/or cGMP for pharmacy compounding and virtual facility inspections. Obstacles encountered during pharmacy compounding related to testing for potential microbial contamination will be covered. Additionally, the challenges presented by COVID-19 pandemic’s impact on the regulatory facility inspection process and the pivot to supporting virtual inspections will be discussed. Recommendations towards achieving regulatory expectations and tips to ensure they are demonstrated to regulators will be shared.

    08:30 | Overcoming the Gap Between 503A and 503B Microbiology-Related Testing
    Abby A. Roth, CMQ/OE, Senior Director of Business Operations, CriticalPoint, LLC.

    09:00 | Virtual Inspections: Paradigm Shift in Inspector/Site Interactions
    Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    09:20 | Q&A Panel

    10:00 – 11:30 | P2: Clean is Not Sterile: A Planetary Science and Planetary Protection Perspective on Cleanroom Microbiology at NASA
    Moderator: MaryEllen E. Usarzewicz, MS, Associate Scientific Director, ASO Microbiology, Bristol-Myers Squibb

    Prevention of microbial contamination as well as cleanroom design pose great challenges for the curation of extraterrestrial samples from NASA’s past and future sample return missions. Microbial monitoring data from existing NASA cleanrooms will be reviewed. Lessons learned from those data, as well as from the pharmaceutical industry and academia regarding design of new laboratories and equipment that will protect both Astro materials and earth from unwanted microbial contamination will be presented. In addition, a Planetary Protection Project will be discussed as it pertains to sampling of the external microbiome of the International Space Station and how results from this research will be used to design facilities for use on Mars in order to limit the amount of contamination associated with crewed missions.

    10:00 | Aaron B. Regberg, PhD, Geomicrobiologist, Planetary Protection Lead, Astromaterials Research and Exploration Science Division, NASA

    11:00 | Q&A Panel

    11:30 – 12:45 | Lunch, Exhibit Hall, Poster Presentations, Exhibitor Tech Talks

    12:45 – 14:15 | Concurrent Sessions

    A3: Contamination Control Strategies: Risk Assessments for Sterile and Non-Sterile Products
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    Contamination control is a challenging and significant issue for the pharmaceutical industry. Steps to identify, assess, and evaluate controls that will minimize risk of the sources of microbial and particulate contamination are necessary. The importance of quality risk management approaches has been recognized in the pharmaceutical industry and has become a valuable component supporting contamination control. In the first presentation, the speaker will discuss important factors, key deficiencies, and knowledge gaps that need attention in products using real-life case studies. Both common contamination causes as well as specific causes of recurrent microbial contamination events across all products will be discussed. In the second presentation, the speaker will provide an overview of the regulations, standards, and guidance documents defining objectionable organisms in various product types. The second presentation will focus on a risk-based method for evaluating the hazards posed by microorganisms in non-sterile manufacturing processes, intermediates, and finished products.

    12:45 | Contamination Case Studies for Sterile, Non-Sterile, Cell and Gene Therapy Products
    Ziva Abraham, PhD, CEO, Microrite, Inc.

    13:15 | What’s Objectionable? Evaluating the Impact of Various Microorganisms in Non-Sterile Manufacturing
    Tiffany A. Baker, MBA, Consultant, ValSource Inc.

    13:45 | Q&A

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

    12:45 | New Annex 1 Facility Assessment: Case study on the Steps Towards Compliance
    Rafael Beaus, Global Consultancy Manager, Azbil Telstar

    13:15 | Designing a Contamination Control Strategy in an Aseptic Cleanroom
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation

    13:35 | Q&A Panel

    14:15 – 15:15 | Exhibit Hall, Poster Presentations, and Exhibitor Tech Talks

    15:15 – 16:45 | Concurrent Sessions

    A4: Surfaces, Water, and Air, Oh My! Tackling Different Contamination Risks
    Moderator: Jason L. Willett, Midwest Manager, Veltek Associates, Inc.

    While contamination can seem like a scary topic, this session will help ease those fears as we explore three distinct areas of contamination risk and provide valuable knowledge to tackle contamination in your own facilities. The first presentation will discuss the real-world factors that negatively impact disinfectant performance and how to avoid them to ensure an effective disinfection program. The second presentation will share case studies of rapid microbial methods (RMM) where the challenge of early detection and response to microbiological contamination of pharmaceutical water were solved. Lastly, the third presentation will present case studies that detail several contamination challenges related to flawed cleanroom and barrier system design or integration as well as how qualification testing did not detect these problems.

    15:15 | Variables Affecting Disinfectant Performance
    Dan A. Klein, MA, Senior Technical Service Manager, STERIS Corporation

    15:35 | Microbiological Quality Control for Pharmaceutical Water by Rapid Microbiological Methods
    Yoko Nakai, Manager, HORIBA Advanced Techno, Co., Ltd.

    16:05 | Sources of Contamination Due to Flawed Barrier System Design, Cleanroom Layout or Integration
    Morgan Polen, Cleanroom, Air Flow and Particle Contamination Expert, Microrite, Inc.

    16:25 | Q&A Panel

    B4: Risky Business: Real World Risk-Based Approaches for Personnel Monitoring and EM Incubation
    Moderator: Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    15:15 | Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium Acnes
    Kenneth W. Boone, Director, Sterile & Microbiology Quality Assurance, Global Compliance, Merck & Co., Inc.

    15:45 | Industry Representative Invited

    16:15 | Q&A Panel

  • Wednesday, 6 October

    07:30 – 08:30 | Registration

    08:30 – 09:45 | The Criticality of Aseptic Training on Product Quality and Patient Risk
    Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

    To ensure critical quality attributes are achieved for aseptically manufactured products, it is essential sterile entry personnel are trained so they have the appropriate level of aseptic-related knowledge to support the successful manufacture of sterile products. This session will explore aseptic training content and approaches to be considered for training sterile entry personnel responsible for manufacturing sterile products. Additionally, a case study will be presented regarding training of staff performing aseptic technique to assess the effectiveness of personnel training and the maintenance of aseptic manufacturing conditions.

    08:30 | Aseptic Training of Sterile Entry Personnel is Imperative to Ensure Sterility of Injectable Products
    Susan L. Ashley, PhD,
    Associate Director, Merck & Co., Inc.

    09:00 | A Case Study: Effective Training Strategies for Personnel Executing Aseptic Activities
    Shelley M. Preslar, MBA,
    President & COO, Azzur Training Center Raleigh LLC

    09:20 | Q&A Panel

    10:00 – 11:30 | P3
    Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio

    10:00 | Panel Discussion
    Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International
    Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol-Myers Squibb
    Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.
    Industry Representative Invited
    Regulatory Representatives Invited

    11:30 – 12:30 | Lunch

    12:30 – 14:00 | Concurrent Sessions

    A5: Advances in Environmental Monitoring Technology and Practices
    Moderator: Josh Eaton, Assistant Director, Scientific Affairs, PDA

    The adoption of Pharma 4.0 concepts and practices presents a need for faster yet still accurate methods for contamination detection. This session will present proof of concept on using BacT/ALERT technology for rapid and sensitive detection of fungal contaminants and a case study on leveraging digital transformation to provide real-time responses to contamination risks, including predictive modeling.

    12:30 | iLYM Media Improves Fungal Detection on the BacT/ALERT for ATMP Sterility Testing
    Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health

    13:00 | Using Machine Learning and Artificial Intelligence to Predict Microbial Risk in Cleanroom Environments
    Tamara Garcia-armisen, PhD, Sterility Assurance Manager, GSK Vaccines-Living Viral Vaccines Manufacturing
    Sander W. Timmer, PhD,Global Director of Analytics & AI, GSK Vaccines

    13:30 | Q&A Panel

    B5: Contamination Control Strategy: Fundamental Aspects and New Technologies
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    With the upcoming revision of Annex 1, defining a robust contamination control strategy is becoming increasingly important. This session will provide additional considerations around a holistic approach to CCS, such as integrated trending, and the opportunity to reevaluate CCS when novel technologies offer a different risk profile.

    12:30 | Shifting Strategies for Contamination Control – Novel Approaches for Novel Technologies
    Joseph E. McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
    Hoang N. Phan, Distinguished Engineer, Network Technology Lead, Genentech

    12:55 | Essentials for a Sound Total Contamination Control Trending Program
    Sheba Zaman, BS, Head of Product Specialists and Training Services, Novatek

    13:25 | Q&A Panel

    14:00 – 14:30 | Break

    14:30 – 16:15 | P4: Ask the Regulators
    Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

    During this interactive session, U.S. FDA will provide insight into questions posed by audience participants. The session is targeted to participants from all segments of the pharmaceutical industry for human and animal drugs and will provide valuable perspectives from agency experts from reviewers of compounding, sterility assurance, aseptic processing, and terminal sterilization of small molecules. In addition, biotechnology professionals can seek input from agency experts on biosimilars and new molecules manufactured using biotechnology processes. Finally, expert field inspectors will provide their perspectives on inspection-related questions. Don’t miss this unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns!

    14:30 | Panel Discussion
    Renée Blosser, MS, Master Microbiology Reviewer, CVM, U.S. FDA
    Rakesh Pandey, PhD, Chief, Regulatory Review Branch-2, CBER, U.S. FDA
    Regulatory Representatives Invited

    16:00 | Closing Remarks from 2022 PDA Global Conference on Pharmaceutical Microbiology Co-Chairs

Highlighted Speakers

Miriam Guest
Miriam Guest
Anna F. Lau
Anna F. Lau
National Institutes of Health
Michael J. Miller
Michael J. Miller
Microbiology Consultants, LLC
Yoko Nakai
Yoko Nakai
HORIBA Advanced Techno, Co., Ltd.
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation
Aaron B. Regberg
Aaron B. Regberg
Astromaterials Research and Exploration Science Division, NASA
Abby A. Roth
Abby A. Roth
CriticalPoint, LLC.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences

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

    Who Should Attend

    More information coming soon.

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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 St NW
Washington, DC

Make a Reservation
Grand Hyatt Washington
  • Accommodations

    Joining us in person? 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 Monday, September 6, 2021. 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 WMATA 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. $42 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

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


Registration Fees

Early Registration

Registration Type: IN-PERSON

Price by 17 Sept. 2021
Member $878
Non-member $1,018
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Early Career Professional

Registration Type: VIRTUAL  
Member/Non-member $878
Regular Registration
Registration Type: IN-PERSON Regular Registration Price after 30 Sept. 2021
Member $1,229 $1,580
Non-member $1,425 $1,832
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Early Career Professional
$615 $790

Registration Type: VIRTUAL  
Member/Non-member $878

* 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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