2023 PDA/FDA Joint Regulatory Conference
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Group Registration
Program Highlights
CDER's Patrizia Cavazzoni, MD and CBER's Peter W. Marks, MD, PhD are confirmed as the opening and closing speakers!
Patrizia Cavazzoni, MD
Peter W. Marks, MD, PhD
The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 32nd year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. This year's theme is CGMP: Quality Through Science and Innovation.
The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts that improve quality and benefit the consumer are also highlighted.
PROGRAM PLANNING COMMITTEE
- CAPT Tara Gooen Bizjak, U.S. FDA (Co-Chair)
- Janeen Skutnik-Wilkinson, Moderna, Inc. (Co-Chair)
- Denyse Baker, Eli Lilly and Company
- Paul Balcer, U.S. FDA
- Hong Cai, U.S. FDA
- Douglas Campbell, InterPro QRA
- Christina Capacci-Daniel, U.S. FDA
- Daniel DeCiero, U.S. FDA
- Nicole Deschamps, GSK
- Rebecca Dowd, U.S. FDA
- Christopher Downey, U.S. FDA
- Mary Farbman, Merck & Co., Inc.
- Irving Ford, Adaptimmune
- Rick Friedman, U.S. FDA
- Victor (Ray) Gaines, U.S. FDA
- Marc Glogovsky, ValSource, Inc.
- Sharyl Hartsock, Eli Lilly and Company
- Andrew Hopkins, AbbVie Inc.
- Mai Huynh, U.S. FDA
- Ingrid Markovic, U.S. FDA
- Kenneth Nolan, U.S. FDA
- Jackie Veivia-Panter, BioCentriq
- Valerie Whelan, Thermo Fisher Scientific
- Lorraine Wood, U.S. FDA
Livestream
| Conference Elements |
In-Person Attendance |
Livestream Attendance |
|---|---|---|
| Plenary Sessions | Yes | Yes |
| Concurrent Sessions | Yes | Yes |
| Breakfast Sessions | Yes | Select sessions with audio only |
| Ability to Submit Questions for Q&A | Yes | Yes |
| Lunch with the Regulators | Yes | Yes |
| Interest Group Discussions with FDA Participation | Yes | No |
| Exhibit Hall | Yes | No |
| Monday Evening Networking Reception | Yes | No |
| In-Person Networking with Industry and Regulatory Participants, Presenters, and Panelists | Yes | No |
Event Location
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Standard Pricing
Standard Member Price
$2,395GovernmentMember Only
$795
Health AuthorityMember Only
$795
Early Career ProfessionalMember Only
$1,295
StudentMember Only
$495
AcademicMember Only
$795
Non-Member
$2,795
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, 18 SEPTEMBER
07:00 – 19:30 | Registration Open
Beat the Monday morning crowd by picking up your badge on Sunday, 17 September from 14:00 – 19:00!
07:00 – 08:30 | Continental Breakfast
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08:00 – 10:00 | P1: The Future of Pharmaceutical Quality and Achieving Sustainable Compliance FDA's Director of the Center for Drug Evaluation and Research (CDER), Dr. Patrizia Cavazzoni, will give the opening keynote address at the 2023 PDA/FDA Joint Regulatory Conference. She will share her perspectives on the latest initiatives that continue to advance the quality of drugs and prevent drug shortages, including sustainable compliance via vigilant quality systems and senior management oversight. Following Dr. Cavazzoni, Thermo Fisher Scientific's Machelle Eppler and Michelle Logan will provide insights into the synergy benefits between manufacturing and quality – from robust problem solving and team development, to addressing supply chain and contracting relationships. |
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08:00 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs 08:30 | Call to Action: Assuring Quality Through Sustainable Compliance, Vigilant Quality Systems, and Modern Manufacturing 08:55 | Q&A with Dr. Cavazzoni 09:10 |
Industry Perspectives on The Future of Pharmaceutical Quality and Achieving Sustainable Compliance 09:35 | Q&A with Ms. Eppler and Ms. Logan |
10:00 – 10:45 | Networking Break in the Exhibit Area
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10:45 – 12:15 | P2: The Search for Quality and Safety Across Two Realms In aerospace and pharmaceuticals – both complex and highly-regulated industries – safety is paramount. Seeking lessons for the drug industry, the first presenter, Dominic Gates, will discuss the design and quality system failures that led to two tragic Boeing 737 MAX crashes and continuing quality shortfalls in aerospace manufacturing. Just like in the aerospace industry, the importance of design and quality systems to prevent failures and improve operations is also a leitmotif of drug manufacturing. In the second presentation, Toni Manzano will present artificial intelligence (AI) as a useful mathematical tool to monitor a complex wealth of data associated with product and process operations and predict quality "red flags" prior to the manufacture of defective drug product. The presenters will be joined by CDER's Office of Policy for Pharmaceutical Quality Director, Ashley Boam, for a closing panel discussion. |
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10:45 | The Devastating Impact of Design and Manufacturing Quality Lapses at Boeing 11:10 | AI in Drug Manufacturing: Understanding the Processes from a GxP Perspective Ashley B. Boam, MSBE, Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, U.S. FDA |
12:30 – 13:30 | Concurrent Interest Group (IG) Sessions
Grab a boxed lunch and bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!
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IG1: GMP Links to Pharmacovigilance
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IG2: Quality Risk Management
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IG3: Regulatory Affairs
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13:45 – 15:15 | Concurrent Sessions
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A1: Finding the “C” in CGMP: Building a World Class Quality and Regulatory Intelligence Program
Regulatory guidance and requirements are continuously changing across all markets. Monitoring the environment and ensuring your quality system evolves to meet these new requirements is foundational to product quality. This session will share current best practices about how to integrate newly published regulatory and quality requirements including tools, information management, and communication strategies to help you focus on generating impact assessments and not just cataloging information. This session will also explore what the future of regulatory intelligence and surveillance could look like with the advent of AI, machine learning, chatbots, and advanced analytics technology to optimize your ability to focus on interpretation and implementation not just searching and triage. |
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13:45 | Current Best Practices: How to Not Spend All Your Time Searching and Typing 14:10 | From Spreadsheets to Rocket Ships: What Could Be the Future for Regulatory Intelligence? Victor (Ray) Gaines, Branch Chief, OMQ, OC, CDER, U.S. FDA (INVITED) |
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B1: Culture of Communication: Shop Floor to Corporate Oversight Communication, by definition, invariably includes the sharing of information and is fundamental to effective leadership and quality assurance, both within an organization and amongst various external parties. As the workforce of the pharmaceutical industry is comprised of people, an organization's commitment to ensuring effective communication builds the establishment of a mature quality culture and fosters the dissemination and understanding of information. This session will explore the ways in which information sharing via communication can be enhanced and delivered in efforts to increase product quality, operational excellence, and culture. Participants will hear from industry and FDA representatives on the ways to harness effective communication strategies, and example case studies that unearth some of the potential benefits to an organization and resultant quality output to patients. |
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13:45 | Culture of Communication: From Shop Floor to Senior Leadership 14:10 | Communications Strategies for the Shop Floor: Fostering Meaningful Peer-To-Peer Communications "In the Flow" of Work Lauren N. Howard, Drug Specialist and Pre-Approval Manager, OMPTO, ORA, U.S. FDA (INVITED) |
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C1: Supplier Audit Program: Managing Risk, Handling Conflicts, and Assuring Quality The obstacles to an effective supplier audit program are well-known and routinely presented at conferences. If you have been involved with a supplier audit program, then it is likely that you have experienced a reluctance to make corrections for audit observations. This session will focus on case studies and insights related to handling conflicts that are generated when there are academic or technical disagreements related to the observations that are documented during an audit. What is the best course of action when your vendor or supplier does not agree with your observation and refuses to develop a corrective action plan? How should the contract-giver document and manage the "regulatory risk" related to the outstanding corrective and preventive action (CAPA)? This session will also address methods to better develop your process for enlightenment and encouragement, while also developing methods for evaluation and assessment of key quality concepts. |
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13:45 | Building Supplier Relationships Through Behavior-Based Cultural Excellence 14:10 | Supply Chain Management Under an Advanced Quality System |
15:15 – 16:00 | Networking Break in the Exhibit Area
16:00 – 17:30 | Concurrent Sessions
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A2: Innovations in CGMP Training Do you still conduct training the old-fashioned way by employing "read and understand" (or is that read and forget)? Presenters in this session will discuss what it will take to transform companies into learning organizations and what do we need to do to get there. |
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16:00 | Learning Culture in the Digital Age 16:25 | Transformational Change in Training 16:50 | Q&A with Additional Panelists |
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B2: Upgrading and Updating Aging Facilities: Quality and Business Advantages The "current" in CGMP shifts with contemporary technology and practices in the industry, so that what was once sufficient may no longer be. Whether it is an aging filling suite, veteran site, or newly acquired facility, improvement may be needed to bring manufacturing to contemporary standards. In this session, the presenters will make the case for these small to large-scale changes based on the obvious impact on product quality and the sometimes less obvious but significant business impact of the investment. |
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16:00 | Increasing Patient Safety by Implementing Updated Technologies 16:25 | The Upside of "Current" 16:50 | Q&A with Additional Panelists |
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C2: Supplier Risk Management: Translating Risk Signals into Actions to Sustain Resilient Supply Chains This session will focus on taking external environmental signals and translating them into action. Presentations will include case studies on how scanning for socio-economic, environmental, and other risks have been used to predict and assess supply chain challenges, drive internal actions, and build resilient supply chains. |
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16:00 | Scan, Focus, Act... For Patients 16:25 | Grappling with the New Normal: Supplier Risk Management Post-Pandemic Ernest F. Bizjak, Compliance Officer/Team Leader, OMQ, OC, CDER, U.S. FDA Brooke A. Trump, MS, Director of Quality, External Manufacturing, Large Molecule, GSK |
17:45 – 18:45 | Concurrent Interest Group (IG) Sessions
Bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!
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IG4: Annex 1 Implementation and GXP Auditing & Inspections
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IG5: Process Validation
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IG6: Vaccines
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19:00 – 22:00 | Grand Opening Reception
Day 2
TUESDAY, 19 SEPTEMBER
07:00 – 18:00 | Registration Open
07:00 – 08:30 | Continental Breakfast
07:15 – 08:15 | Concurrent Breakfast Sessions
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Breakfast 1: Building Quality Science: Insights from St. Gallen's Research The St. Gallen University presents the latest results from a 2-year research project via a grant funded by U.S. FDA. The St. Gallen team applied advanced machine learning methods deriving the importance of quality management practices with the intent to comply with CGMP requirements. Based on this deeper understanding, St. Gallen University has developed a true excellence model that could help with continuous improvement in drug manufacturing. A member of the FDA team will provide FDA's perspective on the project results. |
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07:15 | Building Quality Science: Insights from St. Gallen's Research 07:40 | Q&A with Additional Panelists |
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Breakfast 2: Contamination Control: A Tabletop Exercise A contamination control strategy (CCS) is not just a document you approve to meet a compliance requirement. The CCS highlights the many contamination control principles that a company establishes as part of a holistic approach to designing, controlling, and evaluating various contamination risks. The success of any one CCS element is intrinsically linked to the others, and the success of the CCS depends upon how well the individual elements work together to reduce the contamination hazards for a specific process. When executed well, the CCS facilitates knowledge management and drives continuous improvement. In this breakfast session, participants will learn about the key elements of a robust contamination control strategy as outlined in PDA's newly approved Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR90). The presenter will guide the audience through a scenario-based case study followed by a session debrief. |
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07:15 | Tabletop Exercise Introduction 07:25 | Tabletop Exercise 07:55 | Q&A |
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Breakfast 3: Knowledge Management This interactive session will provide attendees with an update of the work by the PDA Knowledge Management (KM) Roadmap Task Force, including a brief introduction to KM followed by an overview of the team's progress, key insights to date, and planned activities to follow. The Task Force will engage the audience to solicit feedback and ideas regarding the proposed roadmap, as well as potential case studies and best practices to uncover, to better understand the needs of industry and of regulatory agencies as this Task Force continues to advance understanding and competency in KM for the industry. |
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07:15 | Charting PDA's Path to Advance Knowledge Management 07:40 | Q&A with Additional Panelists |
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Breakfast 4: Continuous Manufacturing and Publication of ICH Q13 With the implementation of ICH Q13 - Continuous Manufacturing of Drug Substances and Drug Products in 2023, the big question becomes: what barriers to the development of continuous manufacturing processes remain? Advanced manufacturing technology, including continuous manufacturing, has the potential to improve product quality and reliability, lower costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Because of this potential, FDA and others have encouraged and prioritized development of continuous manufacturing. However, so far, the opportunities presented by advanced manufacturing have not yet been realized as significant numbers of applications. This session will discuss the remaining challenges in the development and implementation of continuous manufacturing processes now that ICH Q13 is in place. Presenters will offer perspectives and discussion on the technical and regulatory hurdles, both real and perceived, that remain to realizing the potential of continuous manufacturing technology for commercial drugs and biologics. |
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07:15 | Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA (INVITED) 07:40 | Q&A with Additional Panelist |
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08:30 – 10:15 | P3: Center Office Updates The global regulatory landscape is evolving. How will the U.S. FDA continue to optimize its strategies and actions to accomplish its mission to safeguard the quality, safety, and effectiveness of medicines for patients, even with current manufacturing and supply challenges? After introductory presentations on current Center activities, your questions will be posed to executive management from various FDA Centers! In a roundtable format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space. |
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08:30 | CBER Updates 08:45 | CDER Updates 09:00 | CVM Updates 09:15 | ORA Updates |
10:15 – 11:00 | Networking Break in the Exhibit Area
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11:00 – 12:45 | P4: Compliance Office Updates Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a roundtable format, FDA's top leaders in compliance and enforcement will describe their programs, initiatives, and recent actions related to inspections and compliance. Current regulatory challenges and FDA's current enforcement strategy for a wide array of medical products will be addressed. This is a great opportunity for you to understand FDA's thinking and expectations for industry compliance. In addition, there will be ample time for the audience to ask questions of FDA's senior leadership. |
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11:00 | CBER Compliance Updates 11:15 | CDER Compliance Updates 11:30 | CVM Compliance Updates 11:45 | ORA Compliance Updates |
13:00 – 14:00 | Concurrent Interest Group (IG) Sessions
Grab a boxed lunch and bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!
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IG7: Biopharmaceutical Manufacturing and Facilities & Engineering
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IG8: Data Integrity and Technology Transfer
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IG9: Pharmacopeial
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14:15 – 15:45 | Concurrent Sessions
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A3: The New ICH Q9 Guideline: The Next Generation of Quality Risk Management Earlier this year, a major revision of ICH Q9 Quality Risk Management was published. This internationally harmonized guideline provides invaluable updates relating to lifecycle management of quality risks, based on practical industry and regulatory experience gained with the original guideline. Improved guidance and training materials on minimizing subjectivity, shortage risks, formality, and risk-based decision making, hazard identification and risk reviews. This session will provide insights from the ICH workgroup who prepared the revised guidance, and industry insights on implementation. |
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14:15 | Overview of Changes to the ICH Q9R1 Guideline: Critical Evolutions in Risk Management 14:40 | Lifecycle Management of Risks to Ensure an Ongoing State of Control 15:05 | Q&A |
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B3: Recently Published Guidances on CGMP and Quality In this session, participants will learn about recent FDA guidance documents that promote improved CGMP compliance, quality, and protect public health. While guidance documents are not enforceable, they are important tools to provide clarity on compliance issues and they are a mechanism for FDA to publicly comment on, and to provide actionable steps to address compliance and high-risk topics. Presentations will include specific cases, to be followed by an extended panel Q&A. |
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14:15 | What’s New in Pharmaceutical Quality (v. 2023) 14:40 | Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: FDA Draft Guidance for Industry 15:05 | Q&A with Additional Panelist |
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C3: Lifecycle Risk Management and CGMP Adaptations to Prevent Nitrosamine Impurity Formation The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in human drugs has caused a global safety concern for industries, health authorities, and patients and even resulted in batch recalls or delayed marketing for some drugs. This session will discuss the current understanding of the potential root causes of nitrosamine impurities. It will address the important role of CGMP compliance, and the impact of drug components, supply chains, manufacturing facility competencies, ongoing testing, and other quality risk management strategies to detect, prevent, and mitigate nitrosamine impurities in drug products based on sound science for delivery of consistent quality drugs for patients. |
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14:15 | Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View 14:35 | A Case Study in Mitigating Nitrosamines Challenges 14:55 | Milind Ganjawala, MS, MBA, Division Director, OC, CDER, U.S. FDA (INVITED) 15:15 | Q&A |
15:45 – 16:30 | Networking Break and Passport Drawing in the Exhibit Area
16:30 – 18:00 | Concurrent Sessions
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A4: Data Integrity: A Key to Innovation The recent release of two FDA discussion papers addressing ML/AI highlights the unique opportunities arising in drug development and manufacturing through application of advanced digital technologies. Rapid, technological leaps in the way we collect, manage, exchange, and analyze data have transformed the data value chain, empowering a seismic shift in the way we create/manage knowledge. Fundamental to enabling data as our most valuable asset is assuring data integrity. With digital transformation, industry has shifted from data integrity compliance to data integrity by-design, adopting data governance principles to integrate data control strategies. This evolution has positioned organizations to proactively seize the ability to harness their data. In this session, presenters will reflect on the data integrity (DI) journey and discuss practical ways where adopting data integrity and governance principles enable organizations to realize data as an empowered asset. The presentations will be followed by a panel discussion with both industry and agency representation. |
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16:30 | Data Integrity: Journey from Compliance to Competitive Advantage Kir F. Henrici, Chief Executive Officer, The Henrici Group 16:55 | Undertaking Data Governance to Enable End-to-End Data Capability 17:20 | Q&A with Additional Panelist |
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B4: PQS Effectiveness: CAPA Effectiveness and Beyond This session will begin with an industry presentation highlighting a case study showing a company that has recently been through a large acquisition and the integration of two quality systems. This first talk will include a focus on the processes, pitfalls, and some of the advantages experienced during the acquisition and integration. The second presentation, by U.S. FDA, will address measuring the effectiveness of the pharmaceutical quality system (PQS) from a regulator's point of view and linking back to the ICH Q10 principles. It will also include some of the more common observations regarding PQS effectiveness as well as investigators' best practices to avoid similar issues. |
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16:30 | A Tale of Two Quality Systems 16:55 | PQS Effectiveness is the Open Secret Robin Kumoluyi, MS, Vice President and Chief Quality Officer, Pharmaceuticals, Johnson & Johnson |
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C4: Excipients are Drugs, Too! The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines components of drugs as drugs. Excipients, a special class of components, must be manufactured in accordance with Current Good Manufacturing Practice (CGMP), but there are no federal regulations stipulating exactly what this means. In this session, the presenters will review the standards that are applied to excipient manufacturing and how drug product manufacturers can ensure their excipient suppliers provide high quality ingredients. Recent inspection and enforcement trends as well as a case study involving resolution of quality challenges at an excipient supplier through collaboration and communication will also be presented. |
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16:30 | Excipient Quality and Recent Cases 16:55 | Excipient GMPs and Excipient Production |
Day 3
WEDNESDAY, 20 SEPTEMBER
07:00 – 15:00 | Registration Open
07:00 – 08:30 | Continental Breakfast
07:15 – 08:15 | Concurrent Breakfast Sessions
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Breakfast 5: Data-Driven Approaches to Improving Manufacturing and Quality Systems Data and metrics drive decisions and manufacturing operations in all types of pharmaceutical and biological firms. Evaluating data in a meaningful way and understanding trends, and other human and process parameters, then acting to improve those processes is critical to meeting quality standards and to improve the overall quality system. Defining useful process metrics and managing the product lifecycle through feedback mechanisms will improve quality. Real-time dashboards and live displays keep production operators and quality personnel updated with the latest information. This session will focus on defining a process and the advanced techniques to establish useful metrics that fit the process and of their outcomes – including production, quality, and how individuals react and act on the data. |
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07:15 | Bioprocess Development and Operation in the Digital Age 07:40 | Q&A with Additional Panelist |
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Breakfast 6: Fungi 101 There has been a renewed interest and a hot topic as of late in both scientific and entertainment industries about fungi. On our screens, Pedro Pascal and Bella Ramsey are facing the threat of fungal apocalypse in the HBO series, The Last of Us and in the real world, scientists are facing the ever-present threat of potential fungal contamination of pharmaceutical manufacturing facilities. In this session, the presenter will discuss how ubiquitous fungi pose risk to products and patients, the relevance of mold in non-sterile and sterile environments, understanding where the potential blind spots are in microbial contamination, how the presence of fungi in facilities can lead to contaminated products, conducting thorough investigations and CAPA, and effective cleaning and disinfection. Participants will leave this breakfast with a better understand fungus among us. |
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07:15 | The Infamous and Misjudged Fungi 07:40 | Q&A with Additional Panelist |
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Breakfast 7: MRA: The Story So Far and What's Next This breakfast session will highlight how and why the Mutual Recognition Agreement (MRA) came about, including the drivers and the process of assessing capabilities, as well as discuss challenges, next steps. |
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07:15 | FDA's Mutual Recognition Agreements: Furthering Our International Collaboration 07:40 | Q&A with Additional Panelists |
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Breakfast 8: Cells to Sales: Ensuring Quality in the Cell Therapy Terrain The journey from clinical to commercial for cell therapies can be challenging. Many manufacturing and regulatory roadblocks, detours, and setbacks may be encountered on the way to the destination. If this is a journey for which you have or planned to embark, this session is just for you. Attend this breakfast to hear from an experienced guide who will help you navigate the best possible routes to bypass and avoid many of the barriers encountered by those who have successfully conquered the journey. |
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07:15 | Successfully Navigating Global Cell Therapy Requirements 07:40 | Q&A |
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08:30 – 10:00 | P5: Current GMP Compliance Trends and Topics This "can't miss" session will include presentations from CDER and CBER and will provide more than just the "Top Ten 483 observations." Participants will gain an understanding of the most recent trends from violative inspections and enforcement actions. This session routinely provides several key topics for attendees to consider and take back for discussion with their team members and colleagues. |
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08:30 | CDER Update 08:55 | CBER Compliance Update 09:20 | Q&A with Additional Panelists |
10:00 – 10:45 | Networking Break
10:45 – 12:15 | Concurrent Sessions
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A5: Quality and Efficiency: Achieving Both Through Process Knowledge The process knowledge that comes from process validation is often thought of as being useful for quality only. A deep knowledge of your process can also be used to improve efficiency while maintaining or improving quality. In this session, participants will learn the fundamentals of process validation principles along with real-world examples of using process validation knowledge to improve quality and efficiency. |
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10:45 | Process Validation: Getting the Full Picture 11:15 | Process Validation for CAR-T Products: A Continuous Journey |
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B5: Revisiting Investigation Specialization: Building a World Class Investigation Process/Program Significant events in our industry rarely have a single cause. Rather, they are initiated by the unexpected interaction of multiple small, seemingly unimportant human errors, technology failures, or bad decisions combined with enabling conditions to produce the event. Becoming normalized to these latent errors remains the single biggest risk we face every day. In this session, participants will learn how some companies are driving culture changes to drive greater action on these latent errors, build world class investigation programs, and avoid disasters. |
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10:45 | Does Your Problem-Solving Strategy Increase Anxiety and Leave Users Feeling Overwhelmed? 11:10 | Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA, U.S. FDA (INVITED) 11:35 | Q&A |
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C5: Managing Suppliers' Corrective and Preventive Actions This session will address the roles of owner(s) and supplier(s) for ensuring compliance with CGMP for the manufacturing activities it performs. A case study will be presented to include the implementation of supplier's oversight over the manufacture of drugs, in particular when a Corrective and Preventive Action (CAPA) plan or change controls are initiated. The role of the owner and supplier or contract facility in managing the risk of the implementation of proposed CAPAs will be discussed, including documentation of actions, findings, and/or changes to the CAPA plan and the communication that should occur to allow effectiveness measurements of such actions. |
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10:45 | Effective CAPA Management Through Supplier Oversight 11:10 | Don't Jump to Conclusions: Ensuring Effectiveness of Supplier CAPAs Kristen L. Anderson, PhD, Microbiologist, ONADE, CVM, U.S. FDA (INVITED) Nicholas A. Violand, Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED) |
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12:30 – 13:30 | Lunch with the Regulators Grab your boxed lunch and bring questions for U.S. FDA investigators, reviewers, and compliance officers to this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives. PANELISTS |
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13:45 – 14:45 | P6: Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies Cell and gene therapy (C>) is a rapidly expanding field offering to deliver curative therapies for many diseases including some rare and ultra-rare conditions. Scientific discovery has been essential to overcoming common challenges resulting from uniquely individualized approaches, associated logistics, and post Covid-related complexities. With growing numbers of regulatory submissions worldwide, innovation in this area has driven changes across the biopharmaceutical sector. This closing plenary will feature world leaders sharing their thoughts on how the field utilizes scientific discovery and innovation to mitigate manufacturing speed bumps, overcoming some of the common pitfalls to achieve robust quality for patients, and streamlining patient access to safe and effective C>s. |
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13:45 | Turning Genes Into Medicines: Scientific Advances Fueling Product Development 14:05 | CAR T Cells: Living Drugs for Immunotherapy 14:25 | Accelerating the Pace of Gene Therapy Development for Rare Diseases 14:45 | Q&A 15:10 | Closing Remarks from Conference Co-Chairs |
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