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
08:00 – 10:00 | P1: The Future of Pharmaceutical Quality and Achieving Sustainable Compliance
Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
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
Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc.
Glenn E. Wright, President and CEO, PDA
CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.
08:30 | Call to Action: Assuring Quality Through Sustainable Compliance, Vigilant Quality Systems, and Modern Manufacturing
Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, U.S. FDA
08:55 | Q&A with Dr. Cavazzoni
09:10 |
Industry Perspectives on The Future of Pharmaceutical Quality and Achieving Sustainable Compliance
Machelle Eppler, Group Vice President Pharma Services Group, Thermo Fisher Scientific and
Michelle P. Logan, Vice President Drug Product Division North America, Thermo Fisher Scientific
09:35 | Q&A with Ms. Eppler and Ms. Logan
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10:00 – 10:45 | Networking Break in the Exhibit Area
10:45 – 12:15 | P2: The Search for Quality and Safety Across Two Realms
Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.
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
Dominic Gates, Aerospace Reporter, The Seattle Times
11:10 | AI in Drug Manufacturing: Understanding the Processes from a GxP Perspective
Toni Manzano, PhD, Co-Founder and CSO, Aizon and Team Leader, AI in Operations (AIO), AFDO/RAPS Healthcare Products Collaborative
11:35 | Q&A with Additional Panelist
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!
IG1: GMP Links to Pharmacovigilance
- IG Leader: Douglas A. Roepke, MD, Associate Vice President, Lilly Global Patient Safety - Medical - Device and Product Safety, Eli Lilly and Company
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IG2: Quality Risk Management
- IG Leaders
- Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
- Malav Parikh, ME, Director, Global Quality Compliance and Systems, Takeda
- FDA Co-Facilitators
- Rick L. Friedman, MS, Deputy Director, OMQ, OC, CDER, U.S. FDA
- Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA (INVITED)
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IG3: Regulatory Affairs
- IG Leader: Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics, Inc.
- FDA Co-Facilitator: Hong Cai, PhD, Division Director, ONDP, OPQ, CDER, U.S. FDA (INVITED)
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13:45 – 15:15 | Concurrent Sessions
A1: Finding the “C” in CGMP: Building a World Class Quality and Regulatory Intelligence Program
Moderators: Denyse D. Baker, PE, RAC, Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company and Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.
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
Denyse D. Baker, PE, RAC, Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company
14:10 | From Spreadsheets to Rocket Ships: What Could Be the Future for Regulatory Intelligence?
Michael de la Torre, MBA, Chief Executive Officer, Redica Systems
14:35 | Q&A with Additional Panelist
Victor (Ray) Gaines, Branch Chief, OMQ, OC, CDER, U.S. FDA (INVITED) |
B1: Culture of Communication: Shop Floor to Corporate Oversight
Moderator: Rebecca E. Dowd, MS, Director, Investigations Branch, Division 3, ORA, U.S. FDA
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
Daniel VonDielingen, MBA, Site Head - Lilly RTP, Eli Lilly and Company
14:10 | Communications Strategies for the Shop Floor: Fostering Meaningful Peer-To-Peer Communications "In the Flow" of Work
Martin J. Lipa, PhD, Principal Consultant, Lipa Group LLC
14:35 | Q&A with Additional Panelist
Lauren N. Howard, Drug Specialist and Pre-Approval Manager, OMPTO, ORA, U.S. FDA (INVITED) |
C1: Supplier Audit Program: Managing Risk, Handling Conflicts, and Assuring Quality
Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA
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
Tami Frederick, Senior Director, Corporate Quality Systems and Cultural Excellence, Perrigo
14:10 | Supply Chain Management Under an Advanced Quality System
Nicholas A. Violand, Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED)
14:35 | Q&A |
15:15 – 16:00 | Networking Break in the Exhibit Area
16:00 – 17:30 | Concurrent Sessions
A2: Innovations in CGMP Training
Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.
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
Nkiruka Ogbuchiekwe, MEd, Senior Director, Leadership, Management, and Culture, Moderna University, Moderna, Inc.
16:25 | Transformational Change in Training
Nicole King, MBA, Associate Director, GMP Training Transformation, AstraZeneca
16:50 | Q&A with Additional Panelists
Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA
Vishal Sharma, MS, Cofounder - Director, Vienni Training & Consulting LLP
David B. Talmage, MBA, Vice President, Education, PDA
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B2: Upgrading and Updating Aging Facilities: Quality and Business Advantages
Moderator: Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA
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
Maik W. Jornitz, Principal Consultant, BioProcess Resources LLC
16:25 | The Upside of "Current"
Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC
16:50 | Q&A with Additional Panelists
Rick L. Friedman, MS, Deputy Director, OMQ, OC, CDER, U.S. FDA (INVITED)
Erica C. Fullam, MS, Senior Director, Production, GSK
Karolyn Gale, VP Regulatory Affairs, Emergent BioSolutions
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C2: Supplier Risk Management: Translating Risk Signals into Actions to Sustain Resilient Supply Chains
Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK
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
Eric L. Berg, Interim Quality Site Head, Amgen Inc.
16:25 | Grappling with the New Normal: Supplier Risk Management Post-Pandemic
Dionne Dosa, MHL, Executive Director, CMC Procurement, Moderna, Inc.
16:50 | Q&A with Additional Panelists
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!
IG4: Annex 1 Implementation and GXP Auditing & Inspections
- Annex 1 Implementation IG Leaders
- Marcia C. Baroni, MBA, Vice President Enterprise GxP Compliance & Systems, Emergent BioSolutions
- Gabriele Gori, SVP Global Quality Head and Chief Quality Officer, Biogen
- Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.
- GXP Auditing & Inspections IG Leaders
- Gabriele Gori, SVP Global Quality Head and Chief Quality Officer, Biogen
- Ghada N. Haddad, PhD, Executive Director, Global Quality Transformation, Merck & Co., Inc.
- FDA Co-Facilitators
- Brooke K. Higgins, MS, Acting Branch Chief, OC, CDER, U.S. FDA
- Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA
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IG5: Process Validation
- IG Leaders
- Robert Dream, Managing Director, HDR Company LLC
- Mauro Giusti, MSc, Senior Director, Site External Network, Eli Lilly and Company
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IG6: Vaccines
- IG Leaders
- Jane L. Halpern, PhD, Executive Director, IAVI
- Sabrina Restrepo, PhD, Director, Vaccines- Technical Product Leadership, Merck & Co., Inc.
- FDA Co-Facilitators
- Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA (INVITED)
- Ingrid Markovic, PhD, Senior Science Advisor, ORO, CBER, U.S. FDA (INVITED)
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19:00 – 22:00 | Grand Opening Reception