2022 PDA Pharmaceutical Microbiology Conference
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Program Highlights
The program agenda is now available!
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.
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 regulatory and pharmacopeial expectations
- Understand global aspects of microbiology and aseptic processing
- Summarize best practices for utilizing EM data to control processes
- Apply some of the lessons learned by the pharmaceutical industry and regulators in a post COVID time
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Standard Pricing
Standard Member Price
$2,395Early Career ProfessionalMember Only
$1,195
Non-Member
$2,695
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
MONDAY, 10 OCTOBER
07:00 – 17:30 | Registration Open
07:30 – 08:30 | Continental Breakfast
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08:30 – 10:00 | P1: Antibiotics: A Double-Edged Sword! |
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08:30 | Welcome from Program Planning Committee Co-Chair 08:45 | The Two-Edged Sword of Antibiotics 09:30 | Q&A |
10:00 – 10:45 | Refreshment Break
10:45 – 12:15 | Concurrent Sessions
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A1: Redefining Environmental Monitoring |
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10:45 | Ways to Evaluate Environmental Monitoring Data as part of a Robust Contamination Control Strategy 11:05 | Changes in the new revision to PDA Technical Report #13, Fundamentals of an Environmental Monitoring Program 11:25 | Q&A |
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B1: Do You Manage Contamination or Does It Manage You? |
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10:45 | Remediation of Contaminated Protein A resin: Guidance for Operational Teams 11:10 | 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 11:30 | Systematically Safeguarding Container Closure System for Controlling Microbial Contamination 11:55 | Q&A |
12:15 – 13:45 | Grand Opening of the Exhibit Hall, Networking Lunch, and Poster Presentations
13:45 – 15:15 | Concurrent Sessions
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A2: Cleanroom Classics There must be contamination control strategy documentation to support the qualification of clean rooms. The presentations included in this session will explore the differences in clean room qualifications versus monitoring along with a case study on common mistakes and misunderstandings in non-viable particle counting. In addition, there will be a session on the evaluation of a ready to use disinfection regimen to support a contamination control strategy. |
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13:45 | The Five Micron Particle Dilemma, Common Mistakes and Misunderstandings in Non-Viable Particle Counting (Cleanroom Classification and Monitoring) 14:10 | The Evaluation of a Ready to Use Combination Disinfection Regimen to Support a Contamination Control Strategy 14:30 | Cleanroom Qualification vs. Monitoring: Differences in Regulatory Expectations 14:55 | Q&A |
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B2: Making it Happen: Applications of Rapid Microbiological Methods |
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13:45 | Development of Improved Mold Recovery for Rapid Sterility Testing Using an Automated Culture System 14:10 | Analysis of Short-Term Variations of Microbiological Loads in Purified Water as a Valuable Tool for Root Cause Investigations: Comparison with Culture-Based Methods 14:30 | Key lessons learned from ongoing pre/post-Implementation of two Automated EM systems within Merck 14:55 | Q&A |
15:15 – 16:00 | Networking Break and Poster Presentations in the Exhibit Hall
16:00 – 17:30 | Concurrent Sessions
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A3:Test for Sterility: Limitations and the Future This session will challenge current thought processes and associated methodologies associated with the Test for Sterility. Speakers will also be presenting different approaches to the realities of the Test for Sterility and how to best move the industry forward. The principles of parametric release are well-described in USP and in other global guidance and standards – is there a pathway for this to become the release mechanism for sterile product? |
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16:00 | In Pursuit of an Ideal Sterility Test: A novel Approach-Based on Raman Spectroscopy and Multivariate Analysis 16:25 | Parametric Release for Products Terminally Sterilized with Moist Heat: A Call to Action 16:55 | Q&A with Additional Panelist |
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B3: The New Annex 1 is Coming! Are you Ready? Annex 1 has been under revision for quite some time and the new version is anticipated to be enacted in the Fall of 2022. As a result, facilities need to prepare. During this session we will highlight the main requirements for Annex 1 with a practical business case for implementation and compliance. We will also equip the audience with the ability to design an effective risk-based approach to cleaning and disinfection by improving contamination control, understanding expectations, and meeting regulatory requirements including Annex 1.Lastly, we will dive into a mold recovery case study detailing the tools/methods used to determine a root cause and the appropriate actions taken to prevent future occurrences. Please join us for what is sure to be an engaging session with many valuable takeaways for the audience. |
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16:00 | Latest Updates on Reviewed Annex 1 and How to Move Ahead Towards its Compliance 16:25 | Key Elements to consider for a successful Cleanroom Cleaning and Disinfection Program 16:45 | Mold Recovery in Grade A: What does Investigation Entail? 17:05 | Q&A |
17:30 – 18:30 | Networking Reception and Poster Presentations in the Exhibit Hall
Day 2
TUESDAY, 11 OCTOBER
07:00 – 17:30 | Registration Open
07:00 – 08:30 | Continental Breakfast
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07:15 – 08:15 | Breakfast Session: Current Struggles with a Panel of Experts |
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07:15 | Panel Discussion |
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08:30 – 10:00 | P2: Changing Dynamics in Science: Implementation by Pharmaceutical Industry and Future Adaptation Change is inevitable! Science is continually evolving and advancing. Humans and society have always been hesitant to change. Despite innovative advances in pharmaceutical microbiology, implementation of new technology and science has been slow. Specifically, advances in rapid microbiological testing methods have not been widely implemented by manufacturers, mainly due to the fear of finding unknowns and non-acceptance by regulators. Despite enhanced knowledge of novel technologies, and the concept of dynamic good manufacturing practices (GMPs for 21st Century), there is a constant struggle in adapting new innovations. This presentation will provide an overview of role of pharmaceutical microbiology in ensuring quality of medicines with examples of changes in microbiological methods, their implementation by the industry to build quality in the product (quality by design, QbD) for achieving sustainable compliance. |
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08:30 | Pharmaceutical Microbiology in Quality of Medicines: Historical Perspectives in Achieving Sustainable Compliance through Evolving Science 09:30 | Q&A |
10:00 – 10:45 | Networking Break and Poster Presentations in the Exhibit Hall
10:45 – 12:15 | Concurrent Sessions
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A4: Wouldn’t It be Nice to Have Expert Advice? Microbiological Investigations: Execution, Documentation, Confirmation, and Regulation Microbiologists gain the most experience and knowledge when events do not go as planned. Still, wouldn’t it be nice to have an expert guide to help Microbiologists navigate the investigation process? Well that help is here! Kim Sobien was part of the team that created Technical Report (TR) #88 - Microbial Data Deviations in the Pharmaceutical Industry. Kim will provide an overview of this new TR and how it can be used to create thoughtful, scientific, and compliant investigations. The second presentation of this session describes how investigational sampling was able to determine root cause in a contamination event. Steven Wieczorek will present the use of Investigational testing to improve contamination control practices by identifying hard to clean surfaces of equipment. Lastly, this session includes Regulatory Expert, Renée Blosser, who will provide an U.S. FDA perspective on Microbiology investigations, root cause determination, and CAPA effectiveness. |
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10:45 | PDA Technical Report #88 - Microbial Data Deviations in the Pharmaceutical Industry 11:10 | Improvement of Contamination Control Practices Using Investigational Testing 11:30 | Regulatory Perspective 11:55 | Q&A |
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B4: Getting Serious about Reducing Animal Testing |
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10:45 | Assessment of Recombinant Factor C Enzyme Critical Quality Attributes and Impact on Assay Performance 11:05 | Three years of MAT Proficiency Test Program 11:25 | The Assessment, Challenges, and Benefits of Implementing an Alternative Endotoxin Method with the use of rFactor C 11:50 | Q&A |
12:15 – 13:45 | Networking Lunch and Poster Presentations in the Exhibit Hall
13:45 – 15:15 | Concurrent Sessions
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A5: Objectionable Microorganisms in Nonsterile Pharmaceutical Products This session will take a fresh look at the long-standing issue of defining what is an objectionable microorganism for nonsterile drug products. Do the current and new regulatory guidelines reflect reality? What are the true risks to the patient and how are objectionable microorganisms determined when establishing microbial limits? Case studies will be presented on Burkholderia cepacia complex (BCC) related to recent product recalls, 483s, warning letters, and facility shutdowns. Information on where BCC is recovered, how best to confirm BCC presence, and steps to eliminate contamination and prevent its reoccurrence will be presented. |
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13:45 | Objectionable Microorganisms-A Challenge or a Dilemma 14:15 | Case Studies on Burkholderia cepacia complex (BCC) Investigations and Remediation 14:45 | Q&A |
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B5: The Contemporary Pharmaceutical Microbiology Laboratory: Balancing Novel Technology and Traditional Microbial Identification Methods |
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13:45 | Enzyme Indicators: A Paradigm Shift in H2O2 Cycle Development and Qualification; Case Studies, Applications, and Forward Thinking from a Pharma Working Group 14:10 | Experiences and Practical Concepts for using Enzymatic Indicators in vH2O2 Bio-Decontamination Cycles: Advantages and Considerations of a New Technology 14:30 | Isolator and Cleanroom Optimisation: Case Study on Inter-Related Dependencies and their Impact on Successful Isolator Bio-Decontamination 14:50 | Q&A |
15:15 – 16:00 | Networking Break, Passport Raffle, and Poster Presentations in the Exhibit Hall
16:00 – 17:30 | Concurrent Sessions
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A6: Aseptic Manufacturing from a Product Quality Microbiology Perspective: Considerations and Critical Concepts |
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16:00 | Repurposing a Sterility Test Isolator for Aseptic Processing in a Controlled Area 16:20 | Pragmatic Approach for Facility Disinfectant Validation, 2022: Negotiating the Standards for Biologics, ATMPs, and Small Molecule Manufacturing 16:45 | Microbiological Quality Level: A Different Way to Measure Sterility Assurance and Product Quality 17:10 | Q&A |
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B6: Technology: Time is now to put Alternative Methods in Place! |
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16:00 | Implementing Membrane-Based Water for Injection Production 16:25 | Using Pulsed Light Technology to Enhance Sterility Assurance in a Clinical Scale Isolator-Based Sterile Filling Line 16:50 | Validation of a Mitigation Strategy using a rFC-Based Method to Overcome LER 17:10 | Q&A |
Day 3
WEDNESDAY, 12 OCTOBER
07:00 – 12:00 | Registration Open
07:00 – 08:45 | Continental Breakfast
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07:15 – 08:30 | Breakfast Session: PDA Microbiological Control Related Publications Bring your coffee and join us for an overview and discussion of recent PDA microbiology-related publications on the topics of microbiological controls for ATMP manufacturing and development of a contamination control strategy. Authors from the two technical documents will present an overview of the content and answer questions on the decision processes as to what was included in the drafting of the final product. |
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07:15 | Points to Consider for Microbiological Control in ATMP Manufacturing 07:35 | Contamination Control Strategy Development in Pharmaceutical Manufacturing 07:55 | Q&A |
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08:45 – 10:00 | P3: Innovations to Avoid an Invasive Biopsy |
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08:45 | Liquid Biopsy: Recent Advances and Future Directions 09:30 | Q&A |
10:00 – 10:30 | Refreshment Break
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10:30 – 12:15 | P4: Ask the Regulators During this interactive session, U.S. FDA representatives 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 who assess microbiological quality of non-sterile and sterile drugs and biologics. The panel members have extensive experience in several areas pertaining to product sterility assurance, including terminal sterilization, aseptic processing, and compounding. In addition, expert field investigators 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! |
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10:30 | Panel Discussion 12:00 | Closing Remarks from the 2023 PDA Pharmaceutical Microbiology Co-Chairs |
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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.
The Grand Hyatt Washington Hotel is now sold out! While there are no other Conference room blocks, we recommend checking the following hotels for rooms as they are the closest walkable hotels with availability.
- Conrad Washington, DC Hotel (4 min. walk to Grand Hyatt)
- Moxy Washington, DC Downtown Hotel (5 min. walk to Grand Hyatt)
- Fairfield Inn & Suites by Marriott Washington, DC/Downtown Hotel (9 min. walk to Grand Hyatt)