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2023 PDA Annual Meeting

2023 PDA Annual Meeting

Apr 03 - Apr 05, 2023
New Orleans, LA

Back to the Future: Learning from the Past in a Patient-Centric World

  • Conference
  • The Americas

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Program Highlights

Early registration is going on now until 05 February, with up to $500 in savings!

Overview

The PDA Annual Meeting is the premier meeting on pharmaceutical/biopharmaceutical manufacturing science and technology.

The 2023 theme “Back to the Future: Learning from The Past in A Patient-Centric World” will spotlight the critical connection between our patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor.

This event provides a forum for sharing knowledge on developing new modalities and the adoption of innovative approaches and processes. You will dive into exciting interactive sessions designed for manufacturing leaders, technical experts/scientists, and early career professionals. No matter what your area of focus, you are sure to come away with tangible and practical solutions to improve your operations

Agenda

  • Day 1
  • Day 2
  • Day 3
  • MONDAY, 03 APRIL

    13:00 – 15:00 | P1: Opening Plenary

     

    15:00 – 15:30 | Refreshment Break

    15:30 – 17:00 | P2

     

    17:00 – 18:30 | Grand Opening Celebration in Exhibit Hall

  • TUESDAY, 04 APRIL

    08:30 – 10:00 | P3

    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.

    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

    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
    C1
    Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems

    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

    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

    12:15 – 13:45 | Lunch, Poster Presentations, and Tech Talks in Exhibit Hall

    13:45 – 15:15 | Interest Groups

    INTEREST GROUP
    IG1
    INTEREST GROUP
    IG2
    INTEREST GROUP
    IG3
    INTEREST GROUP
    IG4

    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.

    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 JohnstonPhD, Director, Technology RoadmappingBioPhorum

    17:00 | Q&A
    B2
    Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

    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

    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
    D2
    Moderator: Kate Malachowski, Associate Director, MS&T, Novavax

    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
  • WEDNESDAY, 05 APRIL

    07:00 | Breakfast Session
    Moderator: Kristin Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.

    07:00 | Capabilities Development for Sterile Manufacturing
    Mauro Giusti, PhD,
    Senior Director, Site External Network, Eli Lilly Italia

    07:20 | Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
    Janmeet Anant, PhD, Senior Regulatory Consultant, Millipore Sigma

    07:40 | Knowledge, Skills, and Experiences: Competencies for A Sterility Assurance Professional
    James Vesper, PhD, MPH, Director, Learning Solutions, Valsource, Inc.

    08:00 | Q&A

    08:30 – 10:00 | Interest Groups

    INTEREST GROUP
    IG5
    INTEREST GROUP
    IG6
    INTEREST GROUP
    IG7
    INTEREST GROUP
    IG8
    10:00 – 10:45 | Refreshment Break, and Poster Presentations in Exhibit Hall

    10:45 – 12:15 | Concurrent Sessions

    A3
    Moderator: Peter Makowenskyj, MEng, Director of Design Consulting, G-CON Manufacturing, Inc.

    10:45 | Accelerating Early Phase Development Through Hybrid Manufacturing
    David Frank, PMP, VP Client Development, Azzur Group

    11:05 | Optimization of Aseptic Manufacturing Risk Mitigation Strategies for ATMPs
    Jeff Odum, CPIP, Practice Lead, ATMPs & Biologics, Genesis AEC
    Jason Rossi, Director, Global Engineering, Cell & Gene Therapy, Catalent

    11:25Advances in Gene Editing and the Influence on Novel Therapy Facility Design
    Emily Heffernan, PE, US Director New Process Technology, DPS Group

    11:45 | Q&A
    B3
    Moderator: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    10:45 | Human Factor Control Strategy for Cell & Gene Therapy Manufacturing: Introducing A Frame-By-Frame Risk Profiling & Mitigation Approach
    Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH
    Ron Smith, PhD, Global Head, Janssen Microbiology Quality and Sterility Assurance, Johnson & Johnson

    11:05 | Designing a Training Strategy to Drive Human Error Reduction
    Londa Ritchey, Quality Director, PharmaLex

    11:25 | Implementation of a New Educational Platform
    Frederic Ayers, Advisor - Sterility Assurance, Global Parenteral Products Network, Eli Lilly and Company

    11:45 | Q&A
    C3
    Moderator: Lauren Specchio, Microbiologist (RA III), Baxter

    10:45 | Analytical Lifecycle Management and the Criticality of Method Suitability
    Paul Mason, PhD, Senior Director, Lachman Consultants
    Mrinmoy Nag, PhD, Senior Director, Lachman Consultants

    11:05 | From Risk to Evidence on A Path Towards Knowledge – A Structured Approach
    Rui Almeida, Head MS&T, Valgenesis | 4 Tune Engineering

    11:25 | Creativity, Subjectivity and Bias in Quality Risk Management
    Andrew O’Connor, Consulting Director, ERA Sciences

    11:45 | Q&A
    D3
    Moderator: Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda

    10:45 | Supply Chain Integrity, Sustainability, and Quality: How the Intersection Helps Patients
    James Fries, CEO, Rx-360

    11:05 | How to Accelerate The Supply of Medicines to All Populations Worldwide - A Regulatory Perspective
    Mic McGoldrick, Technical Advocacy and Policy – CMC, Merck & Co., Inc.

    11:25 | Supply Chain Shortages - True Root Causes and Practical Examples
    Stephan Rönninger,
    Quality External Affairs, Amgen (Europe) GmbH
    Emabelle Ramnarine, PhD

    11:45 | Q&A

    12:15 – 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall

    13:45 – 15:15 | P4: Meeting Needs of Patients by Making Available Safe and Effective Medicines 
    Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck KGaA and Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

     

Highlighted Speakers

Amanda McFarland
Amanda McFarland
ValSource, Inc.
Kenneth Paddock
Kenneth Paddock
Baxter

Additional Information

  • Who Should Attend

    Pharmaceutical/Biopharmaceutical Company Industry

    Facilities and Engineering | Manufacturing | Quality Risk Management | Regulatory Affairs

    Job Functions

    Consultant | Director | Executive and Mid-Level Management | Manager/Leader/Supervisor | Manufacturing Application | Project Management | Risk Management | Scientist | Site Head/Plant Manager | Supply Chain | Technical Services

    Departments

    Compliance | Engineering | Executive Management | Information Technology | Laboratory Science | Manufacturing | Product Development | Quality | Research and Development | Regulatory Affairs | Technical Operations | Training | Validation

Got a Question? We have answers

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Travel

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.

Hyatt Regency New Orleans

601 Loyola Avenue
New Orleans, LA

Make a Reservation
Hyatt Regency New Orleans
  • Accommodations
    The Hyatt Regency New Orleans is the headquarter hotel for the 2023 PDA Annual Meeting!

    Rate: $255 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 03 March 2023 (after this date the disounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations

    Online: Click on the reservation link above
    Phone: +1 (504) 561-1234, make sure to give the PDA Group Code, G-PDAA, to receive the discounted conference rate

    Individual Cancellation

    72 hours prior to 23:59 local time of the day of arrival to check-in to avoid one night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Discover the culture of the Crescent City at Hyatt Regency New Orleans. Centered downtown near Champions Square, Smoothie King Center, and minutes from the historic Mississippi Riverfront. There's no better place from which to explore the eclectic vibrancy of New Orleans.

    Hyatt Regency New Orleans is conveniently located near many popular attractions. They’re only a few minutes walk from the French Quarter and the Arts District. Or hop on the city’s famous streetcars — the Loyola line stops directly outside the hotel.

How to Get Here

By Air

Louis Armstrong New Orleans International Airport (MSY) is approximately 15 miles (24km) from the hotel and all major carriers service this airport. Taxi fares from MSY are approximately $36 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency New Orleans is located at 601 Loyola Avenue, New Orleans, LA 70113. Valet parking is offered at the hotel and there are several nearby parking lots, including the 1301 Girod Parking Garage that connects directly to the hotel. Contact Merit Parking to confirm pricing; +1 (504) 561-0575.

Other Options

Hyatt Regency New Orleans is happy to partner with a local shuttle service to make your trip to and from the Louis Armstrong New Orleans International Airport easy. To learn more, and reserve your spot at least 24 hours prior to your flight arrival time, visit airportshuttleneworleans.com/portals/hyatt-regency-new-orleans.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 05 February
Member $1,995 $2,495
Non-Member $2,395 $2,895
Gov./Health Authority/Academic (Member Only) $795 $895
Student (Member Only) $495 $595
Early Career Professional (Member Only) $1,295 $1,395

* For this member type or discount, online registration is not available, please contact [email protected].

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].

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Contact

Program Inquiries
  • Shannon Sperati, CAE, CMP
    Assistant Director, Programs
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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