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14th PDA Pharmaceutical Microbiology

14th Annual PDA Global Conference on Pharmaceutical Microbiology

Oct 21 - Oct 23, 2019
Rockville, MD

Magnifying the S.C.O.P.E. of Pharmaceutical Microbiology: Science, Compliance, Opportunity, Products, and Engagement

  • Conference
  • The Americas

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Program Highlights

New Regulatory Speakers and Panelists Just Confirmed:

  • Reyes Candau-Chacon, PhD, Quality Assessment Lead (Acting), Division of Microbiology Assessment, Branch IV, CDER, FDA
  • John T. Arigo, PhD, Division Director, CDER, FDA
  • Patricia F. Hughes, PhD, Acting Branch Chief, Division of Microbiology Assessment, CDER, FDA
  • Kevin Rice, Master Chemistry Reviewer, CVM, FDA

Stay Informed to get the updates on speakers, session details, exhibitor information, courses, and more!

Overview

The 14th Annual PDA Global Conference on Pharmaceutical Microbiology 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
  • Day 4
  • Sunday, October 20

    3:00 p.m. – 7:00 p.m.
    Registration Open

  • Monday, October 21

    7:00 a.m. – 5:30 p.m.
    Registration Open

    7:00 a.m. – 8:00 a.m.
    Continental Breakfast

    8:00 a.m. – 9:45 a.m.
    P1: The Perfect Predator
    Moderator: Amy McDaniel, PhD, Microbiology Center of Excellence Leader, Bristol-Myers Squibb

    Epidemiologist Steffanie Strathdee and her husband, psychologist Tom Patterson, were vacationing in Egypt when Tom came down with a stomach bug. Steffanie dosed Tom with an antibiotic and expected the discomfort to pass. Instead, his condition turned critical.

    Local doctors at an Egyptian clinic, an emergency medevac team and then a German hospital failed to cure him. By the time Tom reached the world-class medical center at UC San Diego, where both he and Steffanie worked, bloodwork revealed why modern medicine was failing: Tom was fighting one of the most dangerous, antibiotic-resistant bacteria in the world.

    Frantic, Steffanie combed through research old and new and came across phage theory: the idea that the right virus, aka "the perfect predator," can kill even the most lethal bacteria. Phage treatment had fallen out of favor almost 100 years ago, after antibiotic use went mainstream. Now, with time running out, Steffanie appealed to phage researchers all over the world for help… and together they achieved a major medical breakthrough.

    The Perfect Predator is a nail-biting account of how Steffanie resurrected a forgotten cure—allying with the FDA, researchers from Texas A&M, and a clandestine Navy biomedical center—to design a treatment and save her husband before it was too late. The Perfect Predator is a story of love and against-all-odds survival, detailing how Steffanie helped uncover the science behind a powerful new weapon in the global superbug crisis.

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks from Conference Co-Chair

    8:15 a.m. – 9:15 a.m.
    The Perfect Predator: A Scientist’s Race to Save Her Husband from a Deadly Superbug
    Steffanie A. Strathdee, MSc, PhD, Harold Simon Professor and Co-Director, IPATH, UC San Diego and Author, The Perfect Predator

    9:15 a.m. – 9:45 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 10:15 a.m.
    Refreshment Break

    10:15 a.m. – 11:45 a.m.
    Concurrent Sessions 

    SCIENCE

    A1: Science
    Moderator: MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

    10:15 a.m. – 10:45 a.m.
    Use of Cell Culture Media Microbial Growth Capability as a Potential Tool for the Early Detection of In-Process Contamination
    Rebecca D. Jordan, QC Microbiology Specialist, Celgene

    10:45 a.m. – 11:15 a.m.
    Demonstrating Comparability of Rapid Microbiological Methods: A Practical Approach Using Most Probable Number
    Stacey N. Ramsey, MS, SM(NRCM), Senior Scientist, Microbiology, Alcami Corporation

    11:15 a.m. – 11:45 a.m.
    Questions and Answers/Discussion

    SCIENCE

    B1: Solving Endotoxin Challenges - From Assay to Process Control Strategies
    Moderator: Ed C. Tidswell, PhD, BSc, Executive Director QA, Merck

    Drug products administered intravenously, intrathecally, or intravitreally must all meet compendial requirements for bacterial endotoxin (BET). The diversity and complexity of current (and future) product formulations and manufacturing processes represent new and evolving challenges in BET assay methodology and manufacturing process controls. This session is purposed to provide expert guidance in this field supported by real-life case studies.

    10:15 a.m. – 10:45 a.m.
    Endotoxin OOS: Investigating the Root Cause
    Crystal M. Booth, MM, Regional Manager, PSC Biotech

    10:45 a.m. – 11:15 a.m.
    An Endotoxin Control Strategy for the Purification of Antisense Oligonucleotides (ASOs)
    Hien T. Nguyen, MS
    , Senior Associate Scientist, Biogen

    11:15 a.m. – 11:45 a.m.
    Questions and Answers/Discussion

    11:45 a.m. – 1:30 p.m.
    Grand Opening of Exhibit Hall with Lunch, Poster Presentations, and Tech Talks

    1:30 p.m. – 3:30 p.m.
    Concurrent Sessions

    COMPLIANCE

    A2: Microbial Control Challenges
    Moderator: Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    Aseptic compliance is an ever-changing target that must be continuously reviewed and improved to maintain patient safety and regulatory compliance. In this session, we will discuss developments, challenges, and expectations of Barrier separation technology for Glove Management Strategy, Visual Airflow (smoke) Studies, and GMP Regulatory Inspector Expectations. These discussions will include examples and case studies from real situations. Come and engage in this exciting dialogue.

    1:30 p.m. – 2:00 p.m.
    Regulatory Representative Invited

    2:00 p.m. – 2:30 p.m.
    Glove Management Control Strategy of Aseptic Processing Using Barrier Separation Technology
    Manshi Patel, Associate Director, Merck & Co., Inc.

    2:30 p.m. – 3:00 p.m.
    Characterization of Airflow Patterns, Identification of Barrier System Design Flaws, and Cleanroom/Barrier System Integration Mistakes 
    Morgan Polen, Contamination Control Expert, Microrite, Inc.  

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    OPPORTUNITIES

    B2: Sterility Assurance of Cell-Based and Genomic Therapies
    Moderator: Renée Blosser, MS, Master Microbiology Reviewer, CVM, FDA

    Sterility testing of cell-based and genomic therapies presents unique challenges due to the presence of cells, stability constraints, and small batch size. The development of novel rapid methods and evaluating existing methods provide an opportunity for improved in vitro testing of these therapies to ensure sterility and patient safety while considering the unique profiles of these products. This session will discuss sterility test methods from an industry and regulatory perspective.

    1:30 p.m. – 2:00 p.m.
    Comparative Performance Evaluation of USP, BacT/ALERT Dual-T, and Bactec FX for Contaminant Detection in Cell Products, Viral Vectors, and Radiolabeled PET-Drugs
    James Gebo, QA Manager, Sterility Testing Service, National Institutes of Health

    2:00 p.m. – 2:30 p.m.
    Case Study on the Selection and Validation of a Rapid Sterility Test for a Novel Cell Therapy Oncology Product
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    2:30 p.m. – 3:00 p.m.
    Regulatory Representative Invited 

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    3:30 p.m. – 4:15 p.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    4:15 p.m. – 5:45 p.m.
    Concurrent Sessions

    PRODUCTS

    A3: Keeping Products Safe for Our Patients
    Moderator: Christine Sherman, BA, Global Microbiology, Takeda

    Providing innovative and safe products is the focus of our industry all around the world. This session will provide that perspective of sterility assurance from two different regulatory bodies, Health Canada and the FDA. Representatives from Health Canada will discuss a case study for sterility and endotoxin issues for a natural, sterile product used in wound cleaning. Additionally, the session will provide the FDA view on one of the most critical activities that support sterile products, the media fill.

    4:15 p.m. – 4:45 p.m.
    Sterile Natural Health Products for Wound-Cleaning Failed Sterility and Endotoxin Testing
    Karine Lebel, 
    Microbiologist, Health Canada
    Geneviève Dufour, 
    Microbiologist, Health Canada

    4:45 p.m. – 5:15 p.m.
    Regulatory Representative Invited

    5:15 p.m. – 5:45 p.m.
    Questions and Answers/Discussion

    ENGAGEMENT

    B3: Symbiotic Connections
    Moderator: Irving Ford, MSc, Head, CAR T QC Laboratories, Celgene, Biotechnology Company

    Whether partnering with a regulatory body for a new product, existing product, or just to ask a question or interviewing or collaborating with personnel in your respective organization to complete an investigation, engagement is a key aspect in ensuring success. In this session, we will hear from FDA and industry on how engagement is key to ensuring successful outcomes in establishing/maintaining mutual reliance between industry and regulators as well as in ensuring the involvement of appropriate personnel and data collection to complete a thorough scientifically based investigation.

    4:15 p.m. – 4:45 p.m.
    Regulatory Representative Invited

    4:45 p.m. – 5:15 p.m.
    Key Regulatory and Compendia Elements on How to Investigate a Sterility Test Microbiological Data Deviation: Frantic, Facts, and Fiction
    Dennis E. Guilfoyle, MS, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

    5:15 p.m. – 5:45 p.m.
    Questions and Answers/Discussion

      

    5:45 p.m. – 7:00 p.m.
    Networking Reception and Poster Presentations in Exhibit Hall




  • Tuesday, October 22

    7:00 a.m. – 5:30 p.m.
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Breakfast Session

    8:30 a.m. – 10:00 a.m.
    P2: Genes in Space-3 Project
    Moderator: MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

    In this session, Dr. Sarah Wallace will provide her unique perspective as the Principal Investigator for the Genes in Space-3 Project aboard the International Space Station.

    8:30 a.m. – 9:30 a.m.
    Spaceflight Microbiology: Beyond the Cultures
    Sarah L. Wallace, PhD, Microbiologist, NASA Johnson Space Center

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 7:00 p.m.
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break, Passport Drawing, and Poster Presentations in Exhibit Hall

    10:45 a.m. – 12:15 p.m.
    Concurrent Sessions 

    SCIENCE

    A4: Science
    Moderator: Kim R. Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    10:45 a.m. – 11:15 a.m.
    The Effect of Gamma Irradiation Process Interruption on Microbial Resistance of Healthcare Products
    Fatima Hasanain, MA, 
    Polymer Materials Specialist, Nordion, A Sotera Health Company

    11:15 a.m. – 11:45 a.m.
    Regulatory Representative Invited

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    PRODUCTS

    B1: Products
    Moderator: Ebony S. Arrington, MS, Manager, Production Operations, Pfizer, Inc.

    10:45 a.m. – 11:15 a.m.
    Regulatory Representative Invited

    11:15 a.m. – 11:45 a.m.
    Contamination Control Testing/Release Strategy for CAR T Products
    Irving Ford, MSc, Head, CAR T QC Laboratories, Celgene, Biotechnology Company

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:15 p.m.
    Networking Lunch, Passport Drawing, Poster Presentations, and Tech Talks in Exhibit Hall

    1:15 p.m. – 3:15 p.m.
    Concurrent Sessions

    COMPLIANCE

    A5: Container Closure Integrity Testing
    Moderator: Bo Chi, PhD, Microbiologist, CDER, FDA

    Container closure integrity (CCI) breaches in parenteral drug products may result in loss of sterility and product contamination. Therefore, CCI should be maintained throughout the shelf-life of these products. In this session, we will discuss the different types of CCI tests including recent advances and challenges and regulatory expectations. CCI will be illustrated with case studies and the impact of plunger stopper movement of pre-filled syringes on sterility and CCI will be discussed.

    1:15 p.m. – 1:45 p.m.
    Reyes Candau-Chacon, PhD, Quality Assessment Lead (Acting), Division of Microbiology Assessment, Branch IV, CDER, FDA

    1:45 p.m. – 2:15 p.m.
    Container Closure Integrity Testing
    Lauren E. Levac, MS, Senior Scientist, PPD

    2:15 p.m. – 2:45 p.m.
    The Impact of Syringe Plunger Stopper Movement on Container Closure Integrity: Microbial Incursion Test 
    Janet Perez-Brown, Associate Research Scientist II, Bristol-Myers Squibb  

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    OPPORTUNITIES

    B5: Opportunities
    Moderator: Leslie A. Furr, MS, SM (NRCM), Associate Scientific Liaison, US Pharmacopeia

    To ensure product quality and safety, it is essential that manufacturing controls take microbiological concepts into account during equipment selection and facility design. In this session, FDA and industry experts will discuss the importance of selecting the appropriate equipment and demonstrate performance examples of these devices to minimize contamination risk. This discussion will also review the key areas in developing an appropriate microbial control program.

    1:15 p.m. – 1:45 p.m.
    Considerations in the Selection of Sterile Connection Devices for Patient Safety
    James P. Agalloco, BEChE, MSChE, MBAPresident, Agalloco & Associates Inc.

    1:45 p.m. – 2:15 p.m.
    How to Audit Sanitary Design of Non-Sterile Product Manufacturing 
    Andrew Dick, MS, Senior Principal QA Microbiologist, Johnson & Johnson  

    2:15 p.m. – 2:45 p.m.
    Regulatory Representative Invited

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break, Passport Drawing, and Poster Presentations in Exhibit Hall

    4:00 p.m. – 5:30 p.m.
    P3: Circle of Leaders: Future Leaders and Experienced Leaders
    Moderator: Irving Ford, MSc, Head, CAR T QC Laboratories, Celgene, Biotechnology Company and Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    As microorganisms must continually adapt to their environment to survive and proliferate, so must a microbiologist/scientist during his/her career. The science of microbiology continues to evolve which presents many different career opportunities for a microbiologist/scientist. The session will highlight the career journeys of experienced leaders as well as up and coming leaders in the science of microbiology and pharmaceutical industry. Come and engage in this exciting dialogue and you too may be surprised at the many opportunities that exist for your career path.

    4:00 p.m. – 5:30 p.m.
    Experienced Managers
    Joyce Hansen, Vice President, Johnson & Johnson Sterility Assurance
    Anil Sawant, Senior Vice President, Global Quality Compliance, Merck

    Future Leaders Who Have Stayed or Become Managers
    Lindsey L. Colvin, Associate Director, Merck
    Ayako Hasegawa, PhD, Associate Director, Allergan

    Independent Contributors
    Jay S. Bolden, Senior Consultant Quality-Biologist, Eli Lilly and Company
    Hilary A. Chan, MS, Principal QC Scientist, Takeda




  • Wednesday, October 23

    7:00 a.m. – 12:30 p.m.
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Breakfast Session

    8:30 a.m. – 10:00 a.m.
    P4: Never Home Alone
    Moderator: Amy McDaniel, PhD, Microbiology Center of Excellence Leader, Bristol- Myers Squibb

    Join Dr. Rob Dunn is this session where he will talk participants through the natural history of the wilderness in their homes, from the microbes in their showers to the crickets in their basements.

    8:30 a.m. – 9:30 a.m.
    Rob Dunn, PhD, Professor, Applied Ecology, NC State University and Author, Never Home Alone

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    10:00 a.m. – 10:30 a.m.
    Refreshment Break

    10:30 a.m. – 12:00 p.m.
    P5: Ask the Regulators Panel Discussion
    Moderator: Yeissa Chabrier-Rosello, PhD, Microbiologist, CDER, FDA and John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA

    10:30 a.m. – 12:00 p.m.
    Panel Discussion
    John T. Arigo, PhD, Division Director, CDER, FDA
    Patricia F. Hughes, PhD, Acting Branch Chief, Division of Microbiology Assessment, CDER, FDA

    12:00 p.m. 
    Closing Remarks from the Conference Co-Chair
    Yeissa Chabrier-Rosello, PhD, 
    Microbiologist, CDER, FDA

     


Highlighted Speakers

Rob Dunn
Rob Dunn
Steffanie Strathdee
Steffanie Strathdee
UC San Diego
Sarah L. Wallace
Sarah L. Wallace
NASA Johnson Space Center

Additional Information

  • Learning Objectives

    Learning Objectives

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

    • 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
    • Deepen their understanding of topics such as microbial risk, microbial control, and endotoxin testing
    • Identify current and future trends in Microbiology
    • Implement improvements at their own facilities using information gained through expert presentations and networking opportunities
    • Identify local regulatory and pharmacopeial expectations
    • Understand global aspects of microbiology and aseptic processing
    • Summarize best practices for utilizing EM data to control processes
  • Who Should Attend

    Who Should Attend

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

    Level of Expertise: Executives, Management, Scientists/Technicians

    Job Function: Scientist/Technician, Research, Analyst, Bench Personnel

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity: Knowledge

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Virtual Attendance

Can't make it to Rockville, MD in person?

Virtual attendance allows you to experience, from the comfort of your home or office, all the presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. Interactive features in the live-stream player allow you to enjoy a collaborative experience that connects you with a community of practitioners from around the world.

Participate virtually at a discounted rate of $1,500!

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.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
Rockville, MD
Phone: +1 (301) 822-9200

Make a Reservation
Bethesda North Marriott Hotel & Conference Center
  • 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 Bethesda North Marriott Hotel & Conference Center. The rate is $249 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Bethesda North Marriott Hotel & Conference Center at +1 (301) 822-9200. Please make 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 6:00 p.m. (EDT) on the date of arrival otherwise specified on your reservation information.

  • Amenities
    The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron, and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 20 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, 24 miles away, and Baltimore-Washington International, 34 miles away.

Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

By Car

Bethesda North Marriott is located at 5701 Marinelli Road, Rockville, MD 20852.

$15 Self Parking

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by August 9
Conference Conference + Workshop
Member $2,195 $3,540
Non-member $2,474 $4,019
Young Professional Member $1,098
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310






Regular Registration
Registration Type Price after August 9
Conference Conference + Workshop
Member $2,795 $4,440
Non-member $3,074 $4,919
Young Professional Member $1,398
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Academic Member $700
Academic Non-member* $800
Student $280
Student Non-member* $310

One Day Only Registration
Member $1,318
Non-member $1,430





* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 22, 2019, no fee will be charged. After Sep 22, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Sep 22, 2019, a full refund will be given minus a $200 fee. After Sep 22, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Workshop Information

Workshop Information

2019 PDA Rapid Microbiological Methods Workshop

October 23-24 | Rockville, MD

The 2019 PDA Rapid Microbiological Methods Workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.

Learn more

Contact

Program Inquiries
  • Brooke Schneider, CMP
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
Exhibition Inquiries
Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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