TUESDAY, 04 APRIL
10:00 – 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall
10:45 – 12:15 | Concurrent Sessions
A1
Moderator: Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.
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10:45 | Blind Spot: EU ATMP Regulation and the Annex 1 Revision
Ryan Murray, Senior Consultant, Valsource
11:05 | Virus Retentive Filtration: 2023 Update
Kurt Brorson, PhD, Vice President, Technical, Parexel International
11:25 | ICH Q5A Revision: Quality Control Through Viral Contamination Risk Mitigation for Monoclonal Antibodies Drugs, Gene Therapies and Beyond
Manjula Aysola, Sr. Regulatory Consultant, MilliporSigma
11:45 | Q&A |
B1
Moderator: Lauren Specchio, Microbiologist (RA III), Baxter
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10:45 | Evaluation of Contamination Control Strategies in Novo Nordisk
Peter Bisp, MA, QA Specialist, Novo Nordisk A/S
11:05 | New Technologies Meeting the Focus on Contamination Control Strategies
Maik Jornitz, CEO, G-CON Manufacturing
11:25 | Clean by Design: Draft ASTM E55 Standard for the Specification, Design, Manufacture, and Test of (Bio-)Pharmaceutical Manufacturing Systems That are Easy to Clean in Place
Richard Hall, Business Development, Rattiinox S.r.l.
11:45 | Q&A
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C1
Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems
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10:45 | Use of Internal and Open-Source Quality Data Indicators for Continuous Quality Improvement and Risk Mitigation Strategies
Deanna Anderson, Senior Director, Lachman Consultants
Carrie Colella, Senior Director, Lachman Consultants
11:05 | Increasing Agility Through Digitalization: A Case Study of E-Data Transfer for Quality and Regulatory Information in Supplier-Customer Relationships
Marius Stoffels, Product Manager, Digital Solutions, Merck KGaA, Darmstadt, Germany
11:25 | True Digital Transformation of a Risk-Based Contamination Control Program Based on Annex 1
Sheba Zaman, Head of Product Specialists and Training Services, Novatek
11:45 | Q&A |
D1
Moderator: Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda
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10:45 | Using SHERPA (Systematic Human Error Reduction via Process Analysis) to Identify and Reduce Critical Risks Involving Human Factors
Mimi Ang, MS, Senior Manager, Operational Excellence, Genentech
Brad Manion, Senior Manager, Operational Excellence, Genentech
11:05 | Patient-Administered Therapies: Where Secondary Packaging Plays a Primary Role
Mark Foster, General Manager, Oliver Design
11:25 | Integrating Patient Centricity as Part of a Drug Development Program
Bikash Chatterjee, CEO, Pharmatech Associates
11:45 | Q&A
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12:15 – 13:45 | Lunch, Poster Presentations, and Tech Talks in Exhibit Hall
13:45 – 15:15 | Interest Groups
15:15 – 16:00 | Refreshment Break and Poster Presentations in Exhibit Hall
16:00 – 17:30 | Concurrent Sessions
A2
Moderator: Kristin Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.
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16:00 | Key Considerations in Biologic Drug Product Process Development
Sonia Bedi, PhD, Associate Director, Regeneron
16:20 | Novel Algorithm to Identify Largest Design Spaces
Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH
16:40 | BioPhorum Industry Vision Roadmap 2.0 and Collaboration Case Study: NIMBL-BioPhorum Buffer Stock Blending System
Nandu Deorkar, PhD, Associate Vice President, Research & Development, BioPhorum Production, Avantor
Andrea Johnston, PhD, Director, Technology Roadmapping, BioPhorum
17:00 | Q&A |
B2
Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter
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16:00 | Understanding and Controlling Pre-Sterilization Bio-Burden in Terminally Sterilized Products
Paul Lopolito, Technical Services Senior Manager, STERIS Corporation
16:20 | Rapid Micro Methods: How Should We Design and Sustain the Right Validation Strategy? A Case Study Based on A Rapid Sterility Method
Joanny Salvas, Senior Manager, Pfizer
16:40 | A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug and Medical Device Borne Endotoxin
Edward Tidswell, Executive Director AQ, Merck & Co., Inc.
17:00 | Q&A |
C2
Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck KGaA |
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16:00 | Insights from Mapping API Inspection Deficiencies to the Quality Systems
Jerry Chapman, MBA, Senior GMP Quality Expert, Redica Systems
16:20 | Visualizing Document References and Area of Interest Using Graph Theory and Machine Learning
Mike Salem, Associate Director of Data Science - Quality Assurance, Gilead Sciences
16:40 | From Data Integrity to Quality Intelligence
Ulrich Köllisch, Associate Partner, GxP-CC
17:00 | Q&A
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D2
Moderator: Kate Malachowski, Associate Director, MS&T, Novavax
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16:00 | The Value of Proactive Regulatory Surveillance – A Company’s Perspective
Sinead Redmond, MSc, Snr. Director Regulatory Compliance, Bristol Myers Squibb
Sarah Barkow, PhD, Director External Engagement, Bristol Myers Squibb
16:20 | Correlating Product and Inspection Data to Anticipate Quality Risks in Your Supply Chain
Bob Buhlmann, Head of Quality Digital Strategy, AstraZeneca
Michael de la Torre, Chief Executive Officer, Redica Systems
16:40 | Same Raw Materials, New Product Risk: Applying Risk Management Principles to Raw Material Fit-For-Function Assessment in A World of Cell and Gene Therapy
Kara Quinn, Senior Consultant, ValSource, Inc.
17:00 | Q&A
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