14th Annual PDA Global Conference on Pharmaceutical Microbiology
Registration Options
Individual Registration
Group Registration
Program Highlights
Listen to Keynote Speaker, Dr. Steffanie Strathdee, an infectious disease epidemiologist and author of the book, The Perfect Predator: A Scientist’s Race to Save Her Husband from A Deadly Superbug, discuss her quest to save her husband after he contracted a lethal, antibiotic-resistant superbug, how science can overcome the threat of antibiotic resistance, and how important it is for pharma manufacturing professionals to understand the threat of dangerous microbes.
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.
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
Livestream
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!
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
Training Course Inquiries
Registration Customer Care
Standard Pricing
Standard Member Price
$2,795Non-Member
$3,074
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].
Day 1
Sunday, October 20
3:00 p.m. – 7:00 p.m.
Registration Open
Day 2
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. To kick off the Conference, our first plenary speaker has had the unique perspective of experiencing all five of our topic areas of SCOPE in a very personal way. She has explored and developed the Science, followed the aspects of Compliance, sought out and in some cases created her own Opportunities, produced a specific Product, and Engaged with other scientists, doctors, and regulators in order to save a very special patient, her own husband. This incredible story will set the stage for our Conference and leave our audience of microbiologists inspired to continue their focus on innovating, producing, controlling, and releasing life-saving medicines for patients everywhere. |
|
8:00 a.m. – 8:15 a.m. 8:15 a.m. – 9:15 a.m. 9:15 a.m. – 9:45 a.m. |
9:45 a.m. – 10:15 a.m.
Refreshment Break
10:15 a.m. – 11:45 a.m.
Concurrent Sessions
SCIENCEA1: Evolving the SCOPE As patient, new product technologies and regulatory expectations evolve we are called upon to explore Science, Compliance, Opportunities, Products, and Engagement in innovative ways in order to demonstrate microbial control. In the cell therapy arena, the use of cell culture media, offers both challenges as well as opportunities regarding a contamination control program. This session will explore the use of cell culture media used in daily manufacturing activities as a potential tool to predict or detect in-process contamination. Additionally, as we strive for increased implementation of Rapid Microbiological Methods throughout the industry, using practical approaches in study design is beneficial. This session will discuss a Most Probable Number (MPN) statistical methodology, using quantitative data from a qualitative test in the implementation of rapid sterility testing.Let’s use sound science to expand our testing capabilities in order to better serve our patients! |
|
10:15 a.m. – 10:45 a.m. 10:45 a.m. – 11:15 a.m. 11:15 a.m. – 11:45 a.m. |
SCIENCEB1: Solving Endotoxin Challenges - From Assay to Process Control Strategies 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. 10:45 a.m. – 11:15 a.m. 11:15 a.m. – 11:45 a.m. |
11:45 a.m. – 1:30 p.m.
Grand Opening of Exhibit Hall | Networking Lunch | Poster Presentations | Tech Talks
Poster PresentationsThe following posters will be presented during Monday's refreshment breaks. |
|
1:30 p.m. – 3:30 p.m.
Concurrent Sessions
COMPLIANCEA2: Microbial Control Challenges 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. 2:00 p.m. – 2:30 p.m. 3:00 p.m. – 3:30 p.m. |
OPPORTUNITIESB2: Sterility Assurance of Cell-Based and Genomic Therapies 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. 2:00 p.m. – 2:30 p.m. 2:30 p.m. – 3:00 p.m. 3:00 p.m. – 3:30 p.m. |
3:30 p.m. – 4:15 p.m.
Refreshment Break | Poster Presentations
Sponsored by Boston Analytical
4:15 p.m. – 5:45 p.m.
Concurrent Sessions
PRODUCTSA3: Keeping Products Safe for Our Patients 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 U.S. 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 U.S. FDA view on one of the most critical activities that support sterile products, the media fill. |
|
4:15 p.m. – 4:45 p.m. 4:45 p.m. – 5:15 p.m. 5:15 p.m. – 5:45 p.m. |
ENGAGEMENTB3: Symbiotic Connections 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 U.S. 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. 4:45 p.m. – 5:15 p.m. 5:15 p.m. – 5:45 p.m. |
5:45 p.m. – 7:00 p.m.
Networking Reception | Poster Presentations
Day 3
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. |
|
7:15 a.m. – 8:15 a.m |
|
8:30 a.m. – 10:00 a.m. 50 years ago, American astronauts first set foot on the moon. There was a lot of attention toward microbiology at NASA at this time. In some ways, microbiology hasn’t changed much at NASA in these past 50 years, but in other ways huge advances are moving the field forward. In this session, Dr. Sarah Wallace will discuss pre-flight and in-flight microbial monitoring for the International Space Station, including the current requirements and risk posture. Dr. Wallace will provide insight into the Genes in Space-3 investigation aboard the space station. This was the first-time microbes were collected, cultured and identified off the planet. She will then discuss the BEST (Biomolecule Extraction and Sequencing Technology) payload which goes beyond culture and implements a direct swab-to-sequencer method. Highlights will also include a better understanding of the ISS Microbiome, The Molecular Space Age as well as microbial considerations with regard to future NASA programs, including The Gateway and Artemis Programs with Mars on the horizon. |
|
8:30 a.m. – 9:30 a.m. 9:30 a.m. – 10:00 a.m. |
10:00 a.m. – 10:45 a.m.
Refreshment Break | Passport Drawing | Poster Presentations
Poster PresentationsThe following posters will be presented during Tuesday’s refreshment breaks. |
|
10:45 a.m. – 12:45 p.m.
Concurrent Sessions
PRODUCTSA4: From Prototype to Patient: The Science of Product Development The space between the first idea and filing a new product in the healthcare world requires many facets to be considered, including method development, validation, user application, product efficiency, and communication of the new product to regulatory bodies. This dynamic session explores the development of a new technology, a case study on process development, and details about a transparency initiative from the U.S. FDA regarding microbiology product quality topics. |
|
10:45 a.m. – 11:15 a.m. 11:15 a.m. – 11:45 a.m. 11:45 a.m. – 12:15 p.m. |
PRODUCTSB4: CAR T Products: Control Strategies and Partnerships The newest products designed to save the lives of critically ill patients require unique production and release strategies ensuring speed and efficiency while maintaining strict microbial control. This challenge has expanded the scope of microbiology on many levels, including the area of partnership with regulatory agencies. This session will highlight contamination control and release strategies for CAR T products as well as FDA case studies related to these novel products. |
|
10:45 a.m. – 11:15 a.m. 11:15 a.m. – 11:45 a.m. 11:45 a.m. – 12:15 p.m. 12:15 p.m. – 12:45 p.m. |
12:45 p.m. – 1:45 p.m.
Networking Lunch | Poster Presentations | Tech Talks
1:45 p.m. – 3:45 p.m.
Concurrent Sessions
COMPLIANCEA5: Container Closure Integrity 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. |
|
1:45 p.m. – 2:15 p.m. 2:15 p.m. – 2:45 p.m. 2:45 p.m. – 3:15 p.m. 3:15 p.m. – 3:45 p.m. |
OPPORTUNITIESB5: Opportunities 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, U.S. 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. |
|
1:45 p.m. – 2:15 p.m. 2:15 p.m. – 2:45 p.m. 2:45 p.m. – 3:15 p.m. 3:15 p.m. – 3:45 p.m. |
3:45 p.m. – 4:30 p.m.
Refreshment Break | Passport Drawing | Poster Presentations
|
4:30 p.m. – 6:00 p.m. 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. |
|
4:30 p.m. – 6:00 p.m. Future Leaders Who Have Stayed or Become Managers Independent Contributors |
Day 4
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. |
|
7:15 a.m. – 8:15 a.m |
|
8:30 a.m. – 10:00 a.m. Working together as a community of microbiologists is critical in advancing the science of microbiology in the pharmaceutical industry. In a unique application of this philosophy of working together, our final plenary speaker engaged citizen scientists from around the world to efficiently collect samples globally, adding to his understanding of the diversity of microorganisms in our own homes. This presentation has implications to the diversity of microorganisms in our manufacturing facilities around the world, since we bring our flora from our homes into the places in which we work. Understanding the nature and interactions of microorganisms on our bodies and even in areas such as shower heads (with potential applications to safety showers in manufacturing facilities), can lead to better risk assessment and appropriate levels of control in low bioburden and aseptic manufacturing facilities. |
|
8:30 a.m. – 9:30 a.m. 9:30 a.m. – 10:00 a.m. |
10:00 a.m. – 10:30 a.m.
Refreshment Break
|
10:30 a.m. – 12:00 p.m. 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 and will provide valuable perspectives from agency experts on the topics of Science, Compliance, Opportunities, Products and Engagement. U.S. FDA reviewers of sterility assurance, aseptic processing, and terminal sterilization for small molecules, as well as reviewers of biotechnology applications will provide their perspective on audience questions. Expert compliance personnel 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! |
|
10:30 a.m. – 12:00 p.m. 12:00 p.m. |
Sponsorship and Exhibit Opportunities are Available!
The 14th Annual PDA Microbiology Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This Conference will bring together industry experts from microbiology, manufacturing, laboratories, compliance, quality, research and development, engineering, validation, regulatory affairs as well as executives, managers, scientists, technicians and analysts.
At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.
For more information about exhibit and sponsorship opportunities, please contact:
David Hall, Vice President, Sales
Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: [email protected]
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE 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 RdRockville, MD ,
+1 (301) 822-9200
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
Rockville, MD 20852
Phone: +1 (301) 822-9200
Reservations: You may begin making hotel reservations on April 21, 2019.
Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
Hotel Accommodations
To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference the PDA Meeting to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.
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. 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.
Travel
Area Airports
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.
Ground Transportation
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.
Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.
Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.
Hotel Parking
Hotel parking for registered guests: $17 daily
Conference Center day guests: $2.50 hourly, max of $30 per day.
The PDA room block is currently full, however there may still be rooms available at the prevailing rate. Please contact the hotel directly at +1 (301) 822-9200 to secure your reservations. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.
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.
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.