Home / Global Event Calendar / PDA/FDA Joint Regulatory Conference 2024

PDA/FDA Joint Regulatory Conference 2024

Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity

09 - 11 September 2024

Westin Washington, DC Downtown

Washington, DC

Educational Sessions | Interest Groups | Networking Opportunities | Exhibit Area

Become a Supporter

Learn More

Closed

Benefit from the Annual FDA Co-Sponsored Pharmaceutical CGMP Conference.

Gain in-depth knowledge and practical understanding via focused sessions, interactive discussions, regulatory updates, and case studies regarding the CGMP requirements of the FDA.

CGMP compliance assures maintenance of a daily state of control, and is the foundation for maintaining robust quality, safety, and efficacy of drug products.

Celebrate the 33rd Annual PDA/FDA Joint Regulatory Conference this September!

The PDA/FDA Joint Regulatory Conference is celebrating its 33rd year of informing, educating, and guiding industry professionals and organizations. This CGMP conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by diligently managing risks to manufacturing and quality.

The vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized as fundamental to assuring Current Good Manufacturing Practice (CGMP) compliance.

Case studies presented throughout the conference will provide practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts to improve quality and benefit consumers will also be highlighted.

Registration for the 33rd Annual PDA/FDA Joint Regulatory Conference is open with early registration pricing through 17 July 2024.

Highlighted Presenters

Key Presenters

Patrizia Cavazzoni, MD

U.S. FDA

Director, Center for Drug Evaluation and Research

Presenter
Read Bio
Peter Marks, MD, PhD

U.S. FDA

Director, Center for Biologics Evaluation and Research

Presenter
Read Bio

Conference Co-Chairs

The Minds Behind the Insights

Janeen Skutnik-Wilkinson

Moderna

Director, Global Quality, Regulatory Intelligence and External Engagement
Read Bio
Milind Ganjawala, MS, MBA

U.S. FDA

Division Director, DDQ2, OMQ, OC, CDER
Read Bio

Schedule

Discover What's Happening Each Day

Download Agenda Download Agenda - Summary

Pre-Agenda08 Sep PDA/FDA Day 109 Sep PDA/FDA Day 210 Sep PDA/FDA Day 311 Sep PDA Workshop11-12 Sep PDA Training12-13 Sep

14:00 – 19:00

Registration Open

15:00 – 18:00

Speaker Ready Room Open

07:00 – 19:00

Registration Open

07:00 – 16:15

Speaker Ready Room Open

07:00 – 08:30

Continental Breakfast

08:00 – 09:15

P1: Opening Plenary

Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna

08:00

Opening Remarks from PDA Leadership and Conference Co-Chairs

Anil Sawant, PhD, Chair, PDA Board of Directors and Senior Vice President, Merck & Co., Inc.
Glenn E. Wright, MA, President and CEO, PDA
Milind Ganjawala, MS, MBA, Co-Chair, PDA/FDA Joint Regulatory Conference 2024 and Division Director, DDQ2, OMQ, OC, CDER, U.S. FDA
Janeen Skutnik-Wilkinson, Co-Chair, PDA/FDA Joint Regulatory Conference 2024 and Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna

08:30

A Regulatory Perspective on Quality, Integrity, and FDA Modernization

Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, U.S. FDA

08:55

Q&A

09:15 – 10:15

Networking Break in the Exhibit Area

10:15 – 12:00

P2: Center Office Updates

Moderator: Milind Ganjawala, MS, MBA, Division Director, DDQ2, OMQ, OC, CDER, U.S. FDA

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 managers 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.

10:15

CBER Updates

Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA

10:30

CDER Updates

Douglas R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA

10:45

CVM Updates

Matthew A. Lucia, DVM, Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA

11:00

ORA Updates

Michael C. Rogers, MS, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA

11:15

Q&A

12:00 – 13:30

Lunch on Own

13:30 – 15:00

Concurrent Sessions

QUALITY SYSTEMS

A1: CAPA Strategy: Moving from Reactive to Proactive

Moderator: Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA

When receiving 483 observations, is your company’s CAPA strategy to do the bare minimum to fix the issue? Do you wait for quality issues to arise instead of being proactive in finding and fixing them? In this session, industry quality professionals and FDA compliance officers will discuss how to be proactive instead of just reacting to issues and observations as they arise. This session will discuss how to 1) assure CGMP compliance by identifying adverse manufacturing and quality signals before they cause failures, and 2) implement effective and proactive CAPAs in response to both 483 observations and internally identified quality risks.

13:30 | Strategic CAPAs: Beyond Fixes, Expanding Impact Across Operations

Jonathan W. Chapman, MS, Senior Policy Advisor, OC, CDER, U.S. FDA

13:55 | Quality Insights: Proactive Strategies and Preventive Measures for Continuous Improvement

Paulien Groll, Head of Compliance Excellence, Takeda

14:20 | Q&A

CURRENT PRACTICES AND INNOVATIONS

B1: CGMP Guidance and Policy Updates

Moderator: Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA

Guidance documents are important tools to provide an insight into FDA regulatory interpretations and stimulate actionable steps to assure quality through robust CGMP compliance. In this session, participants will learn about recent FDA guidance documents that advance public health by promoting improved CGMP compliance and quality.

13:30 | CGMP Guidance and Policy Updates

Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, OPPQ, OPQ, CDER, U.S. FDA

13:55 | Pharmaceutical CGMP Guidance and Policy Updates

Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

14:20 | Q&A with Additional Panelist

Michael Kerrigan, PhD, Supervisory Chemist, ONADE CVM, U.S. FDA

SUPPLY CHAIN

C1: Effective Management and Maintenance of Contract Operations

Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

The pharmaceutical industry has continued the marked shift toward reliance on contract manufacturing organizations (CMOs) in recent years. Many companies now obtain most of their drug product supply from CMOs, rather than producing drugs in-house. The selection of a reliable CMO (or ingredient supplier) and establishing a mutual relationship requires strong quality management systems and processes from both parties. This session will address the importance of knowledge management (KM) and quality risk management (QRM) for evaluating the manufacturing competencies of a CMO/supplier, establishing trust, and developing a sustainable partnership. Elements including tailoring quality agreements, auditing, data integrity/data governance, and lifecycle risk management will be discussed.

13:30 | Applying QRM Principles to Navigate Better Outcomes and Partnerships with Your CMO

Douglas A. Campbell, Senior Consultant, InterPro QRA

13:55 | Applications in QRM and KM to Build Trust, Improve Performance, and Enhance CMO Partnership

Martin J. Lipa, PhD, Senior Research Fellow, Technological University Dublin Pharmaceutical Regulatory Science Team

14:20 | Q&A

15:00 – 16:00

Networking Break in the Exhibit Area

16:00 – 17:30

Concurrent Sessions

QUALITY SYSTEMS

A2: Data Integrity and CGMP: Leveraging Digital Tools

Moderator: Al Kentrup, Executive VP, CISPAC LLC

Modern digital capabilities provide great potential to improve problem identification, data analysis, data sharing, cross-disciplinary reviews, quality decision-making, and efficiency. This session will explore how CGMPs and data integrity (DI) will be well served by implementing modern digital strategies. Presenters will address the persistent industry DI issues, focusing on how digital tools could prevent DI problems, while also cautioning to ensure all digital systems are suitable for their intended use. Participants will leave with a better understanding of novel applications of digital tools in production and laboratory settings to enhance CGMP compliance, DI, quality, and efficiency.

16:00 | Prioritizing Root Causes and Enhancing DI with Monte Carlo Failure Mode and Effect Analysis

Paul Hanson, PhD, Vice President, Head of Lifecycle Management, Innovation, and Strategy, Takeda

16:25 | Assuring Integral Data and Applying Innovative Data Analysis Tools

Shawn Larson, PhD, Development Coordinator, OMPTO, ORA, U.S. FDA

16:50 | Q&A with Additional Panelist

Kevin D. Wojtas, Head, Quality Regulatory Compliance, Takeda

CURRENT PRACTICES AND INNOVATIONS

B2: Quality Risk Management Integration in New Sterile Manufacturing Facilities

Moderator: Mai X. Huynh, MS, Supervisory Chemist, ONADE, CVM, U.S. FDA

Aseptic processing has always been known as one of the highest risk processes. An effective quality risk management (QRM) program is essential in aseptic processing facilities, as risk management can be instrumental in identifying and minimizing potential sources of contamination. This session will outline the important aspects of how to initiate and conduct a QRM process for a new aseptic processing facility or process line. Presenters will share case studies and lessons learned in the effective application of QRM principles and tools, including illustrating steps that can be taken to reduce or eliminate hazards in aseptic process design.

16:00 | De-Risking Your Aseptic Process

Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

16:25 | Unlocking the Power of Prevention Controls in QRM to Optimize Aseptic Processing

Darshana Patel, Associate Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.

16:50 | Q&A with Additional Panelists

Kristen L. Anderson, PhD, Microbiologist, ONADE, CVM, U.S. FDA
Robert J. Ham, MEng, Investigator, OMPTO, ORA, U.S. FDA

SUPPLY CHAIN

C2: Non-Compliant Inspections and PAI Withhold Decisions: Recent Inspectional Findings

Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA

Patients expect, and rely on, safe and effective drug products, which require high-reliability manufacturing. But what happens when circumstances take a different turn? This group of FDA experts will discuss recent notable inspection findings that led to official action indicated (OAI) decisions and product recalls, as well as PAI withhold decisions. Participants in this session will hear case studies on the real-world implications of poor quality and come away with an appreciation of the foundational role of CGMPs in assuring reliable drug quality and availability.

16:00 | OAI Inspections and Defective Drugs

Timothy J. Pohlhaus, PhD, Senior Policy Officer, OC, CDER, U.S. FDA

16:25 | Pre-License and Pre-Approval Inspectional Trends for Biologics

Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

16:50 | Q&A with Additional Panelists

Irene E. Abia-Angeh, PharmD, PhD, Chemist, ONADE, CVM, U.S. FDA
Jonathan G. Swoboda, PhD, Consumer Safety Officer, OCBQ, CBER, U.S. FDA

17:30 – 20:30

Networking Reception

07:00 – 19:00

Registration Open

07:00 – 16:45

Speaker Ready Room Open

07:00 – 08:30

Continental Breakfast

07:15 – 08:15

Concurrent Breakfast Sessions

Breakfast 1: Sterility Assurance: The Role of Supply Vendors, Contract Irradiators, and Laboratories

Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

Sterility combines two processes – irradiation and microbiological assessment. Ancillary products (e.g., gowns and gloves) used in aseptic processing and bio-processing industries must be sterile before use. So how does a drug manufacturer have confidence that these ancillary products meet this requirement? This session will address the standards, activities, controls, logistics, and documentation chain of the processes that deliver sterile products. A panel will also discuss what microbiologists and quality unit personnel can, and should, assess to be confident that these supplies are fit for use.

07:15 | Industry Perspective on Sterility Assurance Roles
Arthur Dumba, Director, The Society for Sterility Assurance Professionals

07:40 | Q&A with Additional Panelists
Mike J. Sadowski, Lead Scientist, Baxter Healthcare
Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA, U.S. FDA

Breakfast 2: Anchoring Quality Management Maturity to Business Outcomes

Moderator: Patrick J. Lynch, PhD, Director, Division of Product Quality Assessment XIII, OPQ, CDER, U.S. FDA

FDA’s Center for Drug Evaluation and Research (CDER) is establishing a Quality Management Maturity (QMM) program to promote the adoption of mature quality management practices that go beyond current GMP requirements. This session will discuss potential advantages of implementing mature quality management practices, assessment of maturity levels, the steps to evolve quality systems, and the impact of QMM practices on business operations and reliability of the drug supply.

07:15 | Utilizing QMM Systems to Meet Business Goals
RJ Doornbos, PharmD, Vice President, Quality Operating Systems and Services, Amgen

07:40 | Q&A with Additional Panelists
Magaly E. Aham, MSc, Senior Director, Quality Compliance, Takeda
Alex Viehmann, Division Director, OPQ, CDER, U.S. FDA

Breakfast 3: Platform Technologies Development, Part 1: GMP and CMC Considerations for Vaccines (RNA)

Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Quality Compliance, BioNTech

Platform technologies are not a new concept per se, however in the last 5-10 years they have come to prominence as an effective way of using prior knowledge to accelerate the introduction of new products especially in the field of RNA medicinal products.

Currently, global regulators from FDA, EMA, WHO, and other agencies are supportive of codifying an approach that would allow streamlined marketing approval of new products that fall within the same manufacturing class. Simultaneously, there are industry led efforts to find the best approach to also apply it to the development phase.

07:15 | Industry Perspective on Platform Technologies for Vaccines
Charalampos Koutsoulas, PharmD, PhD, Director Product Quality, BioNTech SE

07:40 | Q&A with Additional Panelists
Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA
Christina Meissner, PhD, Group Manager, AGES - Austrian Agency for Health and Food Safety GmbH

Breakfast 4: Is That a Particle? Dealing with Particulates in Cell and Gene Therapies (ATMPs)

Moderator: Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA

Explore the critical challenge of particulate contamination in cell and gene therapies (ATMPs). This session will delve into identifying, analyzing, and mitigating particulates to ensure product safety and efficacy. Participants will learn about the latest detection technologies, regulatory requirements, and optimizing practices for contamination prevention. Don’t miss this session addressing one of the most pressing issues in the development and production of advanced therapies!

07:15 | Industry Perspective on Dealing with Particulates in ATMPs
Sarah Bottini, Associate Director, Supplier Quality Supplier Engineer Lead, Bristol Myers Squibb

07:40 | Q&A with Additional Panelists
Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.
John H. Vergara, PhD, Senior Manager, Bristol Myers Squibb

08:00 – 10:15

P3: Compliance Office Updates

Moderator: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie

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. Regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is a great opportunity for participants to understand FDA’s thinking and expectations for industry compliance. In addition, there will be ample time to ask questions of FDA’s senior leadership.

08:30

CBER Compliance Updates

Melissa J. Mendoza, JD, Director, OCBQ, CBER, U.S. FDA

08:45

CDER Compliance Updates

Jill Furman, JD, Director, OC, CDER, U.S. FDA

09:00

CVM Compliance Updates

Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, OSC, CVM, U.S. FDA

09:15

ORA Compliance Updates

Alonza E. Cruse, Director, OPQO, ORA, U.S. FDA (INVITED)

09:30

Q&A

10:15 – 11:00

Networking Break in the Exhibit Area

11:00 – 12:30

Concurrent Sessions

QUALITY SYSTEMS

A3: Aging Facilities: Use of Risk Communication to Address Issues and Ensure Sustainable Product Quality

Moderator: Rebecca E. Dowd, MS, Program Division Director, OPQO3, ORA, U.S. FDA

When it comes to aging facilities, the potential for quality impact-related risks grows over time and may not be readily noticed by those closest to the processes. The risks associated with aging facilities are further compounded when communication streams that enable key stakeholder engagement and decision-making are not fully established. Efforts to stay ahead of aging facility risk require timely communication of information to all relevant parties and decision-makers that are able to implement appropriate action.

In this session, participants will hear from industry leaders on successful aging facility communication paths and the related impact on product quality. Case studies will illustrate the benefits of good facility and equipment communication and the pitfalls when communication channels fail.

11:00 | Industry Perspective on Risk Communication

Nicholas A. Violand, Director, Enterprise Regulatory Compliance, Johnson & Johnson

11:25 | Aseptic Facility Communication and Assessment

Paul R. Palmer, MSc, MBA, Managing Director/Pharmaceutical Consultant, Paul R Palmer Limited

11:50 | Q&A with Additional Panelist

Sandra A. Boyd, Drug National Expert, OMPTO, ORA, U.S. FDA

CURRENT PRACTICES AND INNOVATIONS

B3: Quality Enabling Behaviors

Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna

Discover how behavior modification principles can drive a quality culture within organizations. This session will include a case study on implementing these techniques and insights from a company that successfully adopted behavior modification programs, such as performance reviews, reward systems, and leadership development, to enhance quality. Learn practical strategies to foster quality-focused behaviors in your organization!

11:00 | Behavioral Changes and Management Strategies: Lessons Learned from Sustainable Procurement

Jane Zhang, MBA, Co-Founder & Co-CEO, ETCH Sourcing

11:25 | Quality Behaviors in Action

Jason Kerr, MBS, MBA, Senior Manager, Global Quality, Regulatory Intelligence and External Engagement, Moderna

11:50 | Q&A

SUPPLY CHAIN

C3: De-Risking Your Quality Control Laboratory

Moderator: Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

One of the three main objectives of ICH Q10 is to facilitate continual improvement, identify and implement appropriate improvements in product quality, the manufacturing process, reduction in variability, innovation, and pharmaceutical quality system (PQS) enhancement. This is intended to increase the ability to fulfill a manufacturer’s own quality needs consistently. This session will discuss continual reactive and proactive improvement and use of quality risk management (QRM) to identify and prioritize areas of focus of the quality control laboratories. For example, how can we learn from out-of-specification and out-of-trend results and general laboratory errors to improve the overall laboratory system (e.g., equipment, methodology choices, and automation)? Presenters will explore case studies in chemistry and analytical laboratories.

11:00 | Quality Control Laboratory Case Studies

Andrea Sutter Karpinecz, MS, Vice President of Quality Control, Iovance Biotherapeutics

11:25 | Risk-Proofing Science with a Mindset of Quality Always

Aaron R. Goerke, PhD, Site Quality Head, Merck & Co., Inc.

11:50 | Q&A

12:30 – 14:00

Lunch on Own

14:00 – 15:30

Concurrent Sessions

QUALITY SYSTEMS

A4: Independence of the Quality Unit

Moderator: Irving Ford, MSc, VP of Quality, Adaptimmune

Are you independent or is it just an illusion? The Quality Organization must operate independently and have complete autonomy to make decisions. Often, Quality is guided by the demands of “the organization” and decisions are handed to Quality rather than Quality having the final say. If this is the current culture at your organization or an intruder you are trying to stop in its track in your organization, this session will provide information to guide you in your efforts to change the trajectory with robust preventive tactics. Learn how to finally declare your independence and authority!

14:00 | Industry Perspective on Independence of the Quality Unit

Sean McEwen, MEng, Senior Vice President, Quality Assurance & Environmental, Health, and Safety, AbbVie

14:25 | The Case for Global Quality – Compliance and The Bottom Line

Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

14:50 | Q&A with Additional Panelist

Tracy Guldan, MA, Head of Quality Systems, Civica Rx

CURRENT PRACTICES AND INNOVATIONS

B4: Assuring GMPs Through Implementation of Modern Technologies

Moderator: Patrick J. Lynch, PhD, Director, Division of Product Quality Assessment XIII, OPQ, CDER, U.S. FDA

This session will explore recent advances in process modeling for monitoring, control, and validation in GMP. Participants will gain insights into the tech life cycle, focusing on early planning for validation and compliance from development through commercialization and post-marketing. Presenters will share case studies showcasing applications in both small and large molecule processes, highlighting practical implementations and benefits.

14:00 | Chemometrics for Process Control

Chunsheng Cai, PhD, Chemist, OPQ, CDER, U.S. FDA

14:25 | Towards Advanced Process Modeling for Monitoring and Control of Integrated and Continuous Purification

Kevin Brower, PhD, Global Head of Purification Development, Sanofi

14:50 | Q&A with Additional Panelists

Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA
Gang Wang, PhD, Team Lead (Senior Engineer II), Moderna

SUPPLY CHAIN

C4: Accelerating Robust Manufacturing with Advanced End-To-End Risk Profiling

Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna

Developing a robust fill-finish manufacturing process often requires complex, time-consuming iterations, with no guarantee of finding the lowest-risk, most scalable option. Manual process design and documentation create bottlenecks, hindering safety and automation efforts. This session will highlight a new approach using computer-generated, end-to-end process design, risk assessment, and documentation to streamline operations, reduce errors, and enhance scalability.

14:00 | Fast-Track to Robust Manufacturing: A Case Study on Frame-by-Frame Process Modeling

Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery

14:25 | Quantification of Risk Reduction for Robust Manufacturing: A Case Study Addressing ICH Q9(R1) Requirements

Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH

14:50 | Q&A

15:30 – 16:15

Networking Break and Passport Drawing in the Exhibit Area

16:15 – 17:45

Concurrent Sessions

QUALITY SYSTEMS

A5: Engaging the Whole Organization in Quality

Moderator: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie

It’s not you, it’s me! We have all heard the stories – when companies asked who is responsible for quality, the rest of the organization points to the quality unit. This session will show how this culture can be changed and how the rest of the organization can join this journey, and even lead the process! With insights from FDA and senior industry speakers, participants will leave with a better understanding of how this has and can been done, and the impacts when not done properly.

16:15 | Case Study on Engaging the Whole Organization in Quality

Cormac Dalton, PhD, Vice President of Manufacturing (Europe), AbbVie

16:40 | Industry Perspective on Engaging the Whole Organization in Quality

Melissa S. Seymour, MBA, EVP and Chief Quality Officer, Eli Lilly and Company

17:05 | Q&A with Additional Panelist

Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

CURRENT PRACTICES AND INNOVATIONS

B5: Innovations in GMP Compliance: Embracing Digital Technologies in GMP Manufacturing

Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK

Using industry case studies, this session will highlight both the current and potential applications of machine learning/artificial intelligence (ML/AI) and digital twins in GMP manufacturing facilities. The associated regulatory and quality considerations as well as perspectives on future applications and potential challenges with adoption will also be discussed.

16:15 | AI in Manufacturing

Scot Lindsey, Senior Vice President, Information Officer, Manufacturing and Quality, Eli Lilly and Company

16:40 | Digital Twin Applied to Vaccine Manufacturing

Sandrine Dessoy, Science & Technology Innovation Director, GSK

17:05 | Q&A with Additional Panelist

Damodharan Muniyandi, PhD, Chief Quality Officer – Global Quality & Regulatory Affairs, Sai Life Sciences Ltd

SUPPLY CHAIN

C5: Improving Auditing Programs: Going Beyond a Checkbox Approach

Moderator: Denyse D. Baker, PE, RAC, Associate Vice President, Global Quality Compliance, Eli Lilly and Company

Auditing is a key tool in ensuring robust quality systems and processes so that patients receive safe and effective medicines. Audits can also be tremendously resource intensive requiring expert personnel and significant travel time. To maximize the return on that investment and best use learnings gained to ensure continuous improvement, audit findings need to be integrated with overall quality systems and quality practices. This session will explore best practices for a GMP audit program including how to incorporate current external expectations into an audit plan, how to link risk registers to audit planning and outcomes, and how to incorporate audit learnings back into quality procedures or practices.

16:15 | CMO, Partner, and Internal Audits

David Doleski, Compliance Head for Vaccines, Sanofi

16:40 | Enhancing Quality Systems Through Effective Auditing

Nidia Acevedo, PhD, Senior Vice President, Global Quality Compliance, Eli Lilly and Company

17:05 | Q&A with Additional Panelist

Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, OMPTO, ORA, U.S. FDA

18:00 – 19:00

Concurrent Interest Group (IG) Sessions

IG1: Technology Transfer

Leaders

Mirko Gabriele, PhD, CEO, InfiniteVision
Elizabeth Kramer, PhD, Senior Director, Eli Lilly and Company

IG2: Quality Systems

Leaders

Ghada Haddad, PhD, Executive Director, Global Quality Shared Services and Regulatory Intelligence, Merck & Co., Inc.
Eva M. Urban, MSc, Senior Director, Risk Management, Bristol Myers Squibb

IG3: Drug Compounding AND Sterile Processing/Parenteral Drug Manufacturing

Drug Compounding Leaders

Arie Anahory, MS, Senior Director, Strategy and Customer Excellence, Regulatory Compliance Associates Inc.
David Short, Chief Quality Officer, QuVa Pharma, Inc.

Sterile Processing/Parenteral Drug Manufacturing Leader

Julian Petersen, Head of Global Business Development Pharma, groninger & co. gmbh

IG4: Data Governance, Management, Integrity, and Digitalization

Leaders

Kir F. Henrici, Chief Executive Officer, The Henrici Group
Ulrich Koellisch, PhD, Partner, GxP-CC GmbH

IG5: Quality Risk Management

Leaders

Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
Malav Parikh, ME, Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

IG6: Regulatory Affairs

Leader

Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics, Inc.

07:00 – 15:00

Registration Open

07:00 – 11:00

Speaker Ready Room Open

07:00 – 08:30

Continental Breakfast

07:15 – 08:15

Concurrent Breakfast Sessions

Breakfast 5: Disaster Recovery Planning: Updating Your Contingency Plan

Moderator: Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

"By failing to prepare, you're preparing to fail." – Benjamin Franklin

A robust contingency and response plan is crucial for disaster event preparation (e.g., tornado, earthquake, etc.). Recently, a tornado caused severe damage to a sterile facility responsible for manufacturing nearly 50 medicines (equating to approximately 8% of the total U.S. hospital supply). This session will focus on the post-disaster responses, how CGMP operations were restarted, and lessons learned for even better preparation for potential future disaster events.

07:15 | Lessons Learned from Rocky Mount
Bryan Timothy Bassler, PhD, Vice President, Sterile Injectable & Biotech Quality Operations Cluster Lead, Pfizer

07:40 | Q&A

Breakfast 6: X-Ray Technology

Moderator: Mai X. Huynh, MS, Supervisory Chemist, ONADE, CVM, U.S. FDA

X-ray technology emerged as an alternative to gamma irradiation. How practical and/or reliable is this technology as compared to other means of sterilization? What are the hurdles when considering transitioning from gamma-ray sterilization modalities to X-ray? Using X-ray facility case studies, experts will demonstrate compliance with FDA GMP and the types of testing (e.g., physicochemical, mechanical, extractable testing, etc.,) performed on products to fulfil filing requirements.

07:15 | X-Ray Industry Perspective
Betty Howard, MS, MBA, Senior Radiation Sterilization Manager, STERIS Applied Sterilization Technologies (AST)

07:35 | CDRH Master File Pilot Program to Address Modality Transition and Shortage
Ryan A. Ortega, PhD, Regulatory Policy Advisor, OPEQ, CDRH, U.S. FDA

07:55 | Q&A with Additional Panelist
Irene E. Abia-Angeh, PharmD, PhD, Chemist, ONADE, CVM, U.S. FDA

Breakfast 7: Platform Technologies Development, Part 2: GMP and CMC Considerations for Cell and Gene Therapies (ATMPs)

Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

Platform technologies are not a new concept per se, however in the last 5-10 years they have come to prominence as an effective way of using prior knowledge to accelerate the introduction of new products, especially in the field of cell and gene therapies.

07:15 | Industry Perspective on Platform Technologies for Cell and Gene Therapies (ATMPs)
Markus Gruell, MSc, Vice President Head of Quality, Autolus Ltd.

07:40 | Q&A with Additional Panelists
Kathryn Landes, Vice President Global Product Quality, BioNTech
Omar Tounekti, PhD, MBA, Manager, Cell, Gene Therapies and Radiopharmaceuticals Division, Health Canada

Breakfast 8: Building a Bridge: Leveraging Data Governance Towards the Adoption of Emerging Technologies

Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK

We live in an exciting time! Digital transformation, data science, and the utility of emerging technologies, like AI, are fueling the life science industry towards endless opportunities to better serve patients globally. In a good practice (GxP) environment, the promise and potential of these innovations share a common essential asset: regulated data. Assuring the integrity of regulated data is a requirement of GxP regulations, leading many organizations to implement formal data governance programs within the quality management system (QMS). This session will address how, in a rapidly evolving and innovative ecosystem, data governance is mission critical, including establishing principles and measures that can be leveraged to build a bridge towards the compliant adoption of emerging technology.

07:15 | Paving the Way for Innovation and Compliance Through Data Governance
Kir F. Henrici, Chief Executive Officer, The Henrici Group

07:40 | Q&A

08:30 – 10:00

P4: Current GMP Compliance Trends and Topics

Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, ORO, CBER, U.S. FDA

With presentations from CDER and CBER, this can’t miss session will provide more than just the “top ten” 483 observations! Experts will highlight recent trends from violative inspections to enforcement actions giving participants key topics to consider and take back to their team members and colleagues for discussion.

08:30

CDER Updates

Francis RW Godwin, MBA, Office Director, OMQ, OC, CDER, U.S. FDA

08:55

CBER Updates

Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA

09:20

Q&A with Additional Panelists

Marea K. Banks, Consumer Safety Officer, OSC, CVM, U.S. FDA
Ronda R. Loyd-Jones, MBA, Director, Compliance Branch, OPQO, OMPTO, ORA, U.S. FDA

10:00 – 10:30

Networking Break

10:30 – 12:00

P5: Operationalizing Quality Risk Management and Knowledge Management

Moderator: Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA

This plenary session will provide practical insight into how quality risk management (QRM) and knowledge management (KM) are being operationalized in pharmaceutical manufacturing. International regulators and industry experts will present principles and tangible examples illustrating how QRM and KM optimize manufacturing processes, reduce errors, and ensure compliance with regulatory standards, ultimately safeguarding patient health and trust in quality of medicines.

10:30

Operationalizing QRM

Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

10:55

Operationalizing KM

Industry Representative Invited

11:20

Q&A with Additional Panelist

Martin J. Lipa, PhD, Senior Research Fellow, Technological University Dublin Pharmaceutical Regulatory Science Team

12:15 – 13:15

Lunch with the Regulators

Moderator: Rebecca E. Dowd, MS, Program Division Director, OPQO3, ORA, U.S. FDA

In this lunch Q&A session, FDA investigators, reviewers, and compliance officers will answer participants’ questions and provide further insights into inspection trends and center initiatives.

Panelists:

Sandra A. Boyd, Drug National Expert, OMPTO, ORA, U.S. FDA
Alifiya H. Ghadiali, PhD, RAC, Lead Consumer Safety Officer, OCBQ, CBER, U.S. FDA
Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA
Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM, U.S. FDA
Derek S. Smith, PhD, Deputy Director, OPMA, OPQ, CDER, U.S. FDA

13:30 – 14:30

P6: Closing Plenary

Moderator: Mary E. Farbman, PhD, Associate Vice President, Global Quality Compliance, Merck & Co., Inc.

This year’s closing plenary will feature CBER Director Dr. Peter Marks will close out the Conference with a forward-looking presentation.

13:30

The Evolving Landscape of Pharmaceutical Manufacturing

Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA

13:55

Q&A

14:20

Closing Remarks from the Conference Co-Chairs

Activities and Networking Opportunities

Connect and Collaborate

Monuments by Moonlight Trolley Tour

Tuesday, 10 September 2024

Date and time

Tuesday, 10 September / 18:45 – 21:00 ET

Cost

$52 per person, includes private trolley tour and professional live tour guide.

Limit

35 people Max.

About this tour

See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze. Along the way, a professional tour guide will take you back in time as they share historic tales and anecdotes about the city’s fascinating history. Learn about the curse of the Hope Diamond and its legacy of death and despair and hear about the Medal of Honor winner who donated his amputated leg to a museum (and often visited it!). You haven’t seen DC until you’ve seen it at night!

Monuments include the Franklin Delano Roosevelt Memorial, the Korean War Veterans Memorial, the Lincoln Memorial, the Marine Corps War Memorial, the Martin Luther King, Jr. Memorial, the Thomas Jefferson Memorial, the United States Capitol, the Vietnam Veterans Memorial, and the Washington Monument.

Timeline

18:45 Tour participants meet PDA staff in Westin Washington, DC Downtown lobby
19:00 Tour departs from Westin Washington, DC Downtown
21:00 Tour returns to Westin Washington, DC Downtown

Program Planning Committee

The Team Behind the Event's Agenda

Denyse Baker, PE, RAC

Eli Lilly and Company

AVP Global Quality Compliance
Read Bio
Paul Balcer

U.S. FDA

Program Manager, OMQ, OC, CDER
Read Bio
Tara Gooen Bizjak, MBS

U.S. FDA

Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
Read Bio
Francesco Cicirello, PharmD, MSc

BioNTech

Senior Director Global BioNTainer Quality Compliance
Read Bio
Daniel DeCiero

U.S. FDA

Consumer Safety Officer, OCBQ, CBER
Read Bio
Nicole Deschamps, PhD

GSK

Senior Director, External Development Operations and Process Excellence
Read Bio
Rebecca Dowd, MS

U.S. FDA

Program Division Director, OPQO3, ORA
Read Bio
Mary Farbman, PhD

Merck & Co., Inc.

Associate Vice President, Global Quality Compliance
Read Bio
Irving Ford, MSc

Adaptimmune

VP of Quality
Read Bio
Rick Friedman, MS

U.S. FDA

Deputy Director, OMQ, OC, CDER
Read Bio
Marc Glogovsky, MS

ValSource, Inc.

Business Unit Manager - Microbiology
Read Bio
Andrew Hopkins, PGDip

Lachman Consultants

Senior Director
Read Bio
Mai Huynh, MS

U.S. FDA

Supervisory Chemist, ONADE, CVM
Read Bio
Al Kentrup

CISPAC LLC

Executive VP
Read Bio
Patrick J. Lynch, PhD

U.S. FDA

Director, Division of Product Quality Assessment XIII, OPQ, CDER
Read Bio
Ingrid Markovic, PhD

U.S. FDA

Senior Science Advisor, Office of the Center Director, ORO, CBER
Read Bio
Erika Pfeiler, PhD

ValSource, Inc.

Senior Consultant - Microbiology
Read Bio
Jackie Veivia-Panter

Consultant
Read Bio
Kenneth Nolan

U.S. FDA

Senior Advisor
Bio Coming Soon
Lorraine D. Wood, MS

U.S. FDA

Health Science Project Manager
Bio Coming Soon

Promotion and Press

Promote the Conference

Get Shareable Images and Posts

Request Press Pass

Submit Your Information

Supporters

Supporters and Collaborators

Diamond Supporter

Platinum Supporter

Silver Supporter

Bronze Supporter

Exhibitors

Exhibitors and Innovators

Media Partners

Location and Travel

Venue Details and Accommodations

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.

Conference Venue & Hotel Accommodations

Westin Washington, DC Downtown

999 9th Street, NW
Washington, DC 20001, United States

Cancellation Policy
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.

Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to the CityCenterDC outdoor shopping area, the best of the city awaits outside the doors. Unwind in inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The hotel’s complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.

How to Get Here

By Air The Westin Washington, DC Downtown is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 34 miles/55 km).

By Car The Westin Washington, DC Downtown is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($48+/day) and valet parking ($65+/day) are available.

By Other Options The Westin Washington, DC Downtown is easily accessible from the following Metro stops: Gallery Place-Chinatown (Green, Red, and Yellow Lines, 7th St. & H St., NW exit - approx. 0.2 miles/0.3 km) and Metro Center (Blue, Orange, Red, and Silver Lines, 11th St. and G St., NW exit - approx. 0.4 miles/0.6 km).

Registration

Pricing Options

Member Price

$2,895

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$3,295

Member Price

$2,395

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,795

See Qualifying Criteria for Member Types.

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 registration@pda.org.

Presenters

MEET OUR PRESENTERS

Irene Abia-Angeh, PharmD, PhD

U.S. FDA

Chemist, ONADE, CVM

Presenter
Read Bio
Nidia Acevedo, PhD

Eli Lilly and Company

Senior Vice President, Global Quality Compliance

Presenter
Read Bio
Kristen Anderson, PhD

U.S. FDA

Microbiologist, ONADE, CVM

Presenter
Read Bio
Marcia Baroni, MBA

Emergent BioSolutions

VP Quality, Enterprise GxP Compliance & Systems

Presenter
Read Bio
Tara Gooen Bizjak, MBS

U.S. FDA

Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER

Presenter
Read Bio
Sandra Boyd

U.S. FDA

Drug National Expert, OMPTO, ORA

Presenter
Read Bio
Kevin Brower, PhD

Sanofi

Global Head of Purification Development

Presenter
Read Bio
Cindy Burnsteel, DVM

U.S. FDA

Deputy Director for Drugs and Devices, OSC, CVM

Presenter
Read Bio
Chunsheng Cai, PhD

U.S. FDA

Chemist, OPQ, CDER

Presenter
Read Bio
Christina Capacci-Daniel, PhD

U.S. FDA

Consumer Safety Officer, OMQ, OC, CDER

Presenter
Read Bio
Patrizia Cavazzoni, MD

U.S. FDA

Director, Center for Drug Evaluation and Research

Presenter
Read Bio
Jonathan Chapman, MS

U.S. FDA

Senior Policy Advisor, OC, CDER

Presenter
Read Bio
Alonza E. Cruse

U.S. FDA

Presenter
Read Bio
Cormac Dalton, PhD

AbbVie

Vice President of Manufacturing (Europe)

Presenter
Read Bio
Daniel DeCiero

U.S. FDA

Consumer Safety Officer, OCBQ, CBER

Presenter
Read Bio
Sandrine Dessoy

GSK Vaccines

Presenter
Read Bio
Madushini Dharmasena, PhD

U.S. FDA

Senior Pharmaceutical Quality Assessor, OPQ, CDER

Presenter
Read Bio
David Doleski

Sanofi

Compliance Head for Vaccines

Presenter
Read Bio
RJ Doornbos, PharmD

Amgen

Vice President, Quality Operating Systems and Services
Read Bio
Arthur Dumba

The Society for Sterility Assurance Professionals

Director

Presenter
Read Bio
Jill Furman, JD

U.S. FDA

Director, OC, CDER

Presenter
Read Bio
Paulien Groll

Takeda

Head of Compliance Excellence

Presenter
Read Bio
Markus Gruell, MSc

Autolus Ltd.

Senior Vice President Head of Quality

Presenter
Read Bio
Tracy Guldan, MA

Civica Rx

Head of Quality Systems

Presenter
Read Bio
Robert Ham

U.S. FDA

Investigator, OMPTO, ORA

Presenter
Read Bio
Paul Hanson, PhD

Takeda

Vice President, Head of Lifecycle Management, Innovation, and Strategy

Presenter
Read Bio
Brooke Higgins, MS

U.S. FDA

Branch Chief, OC, CDER

Presenter
Read Bio
Betty Howard

STERIS

Senior Radiation Sterilization Manager

Presenter
Read Bio
Laura Huffman, MS

U.S. FDA

CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM

Presenter
Read Bio
Andrea Karpinecz, MS

Iovance Biotherapeutics

Vice President of Quality Control

Presenter
Read Bio
Jason Kerr, MBS, MBA

Redica Systems

Presenter
Read Bio
Michael Kerrigan, PhD

U.S. FDA

Supervisory Chemist, ONADE, CVM

Presenter
Read Bio
Shawn Larson, PhD

U.S. FDA

Development Coordinator, OMPTO, ORA

Presenter
Read Bio
Martin Lipa, PhD

Technological University Dublin Pharmaceutical Regulatory Science Team

Senior Research Fellow

Presenter
Read Bio
Ronda Loyd-Jones, MBA

U.S. FDA

Director, Compliance Branch, OPQO, OMPTO, ORA

Presenter
Read Bio
Matthew Lucia, DVM

U.S. FDA

Director, Office of New Animal Drug Evaluation, CVM

Presenter
Read Bio
Peter Marks, MD, PhD

U.S. FDA

Director, Center for Biologics Evaluation and Research

Presenter
Read Bio
Sean McEwen, MEng

AbbVie

Senior Vice President, Quality Assurance & EHS

Presenter
Read Bio
Ronan McGarvey, MSc

AbbVie

Director, Site Quality – Westport, Ireland

Presenter
Bio Coming Soon
Christina Meissner, PhD

AGES - Austrian Agency for Health and Food Safety GmbH

Group Manager

Presenter
Read Bio
Damodharan Muniyandi, PhD

Sai Life Sciences Ltd

Chief Quality Officer – Global Quality & Regulatory Affairs

Presenter
Read Bio
Paul Palmer, MSc, MBA

Paul R Palmer Limited

Managing Director/Pharmaceutical Consultant

Presenter
Read Bio
Darshana Patel

Merck & Co., Inc.

Associate Director, Micro Quality & Sterility Assurance

Presenter
Read Bio
Timothy Pohlhaus, PhD

U.S. FDA

Senior Policy Advisor, OC, CDER

Presenter
Read Bio
Michael Sadowski

Sterilexcellence

Owner
Read Bio
Melissa Seymour, MBA

Eli Lilly and Company

EVP and Chief Quality Officer

Presenter
Read Bio
Jonathan Swoboda, PhD

U.S. FDA

Consumer Safety Officer, OCBQ, CBER

Presenter
Read Bio
Seneca Toms, MS, MSEH, RAC

U.S. FDA

National Expert, Drugs, OMPTO, ORA

Presenter
Read Bio
Alex Viehmann

U.S. FDA

Division Director, OPQ, CDER

Presenter
Read Bio
Nicholas Violand

Johnson & Johnson

Director, Enterprise Regulatory Compliance

Presenter
Read Bio
Barbara Wilimczyk-Macri, MS

U.S. FDA

Senior Compliance Officer, OMPTO, ORA

Presenter
Read Bio
Kevin Wojtas

Takeda

Head, Quality Regulatory Compliance

Presenter
Read Bio
Jane Zhang

ETCH Sourcing

Co-Founder & Co-CEO
Read Bio

Become a Supporter

Amplify Your Presence and Reach Your Customers!

Become a supporter and/or exhibitor at the only co-sponsored pharmaceutical Current Good Manufacturing Practice (CGMP) conference offered in the United States. As a supporter and/or exhibitor, you'll have unparalleled opportunities to connect with industry leaders, showcase your products and services, and establish your company as a part of the industry.

Become a Supporter

Livestream Details

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