PDA Week 2025

PDT Daylight Time (UTC -7:00)

• 06:00 – 06:30

  Morning Wellness Walk

  Departs from Renaissance Lobby

  Rise and refresh!

  Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

  Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

• 06:30 – 07:30

  PDA Member Lounge Open

  Santa Rosa (Renaissance)

  The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.
• 07:00 – 08:00

  Continental Breakfast

  Lobby

• 07:00 – 18:30

  Registration Open

  Oasis Hall 2

• 07:30 – 16:30

  Presenter Ready Pavilion Open

  Oasis Hall 2

• 08:00 – 09:30

  P2: Sustainability at Scale: Transforming Facilities and Mindsets in Pharma (Oasis Hall 1)

  Oasis Hall 1

  • Moderator:

    

    Sebastian B Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  Pharmaceutical manufacturing is one of the industries leading the charge toward a sustainable future and setting a new standard for environmental responsibility. In this plenary session, Jane Zhang will illustrate how procurement and supply chain innovation will drive transformative behavioral change within organizations. Phil Duncanson will unveil AstraZeneca’s ambitious sustainability journey, from modernizing aging facilities to creating a groundbreaking carbon-neutral site in Singapore. Attendees will gain actionable strategies to champion sustainability as a cornerstone of industry progress.

  • 08:00 – 08:25

    Driving Behavioral Change: Unlocking Sustainability Through Procurement and Supply Chain Innovation

    • Presenter:

      

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

  • 08:25 – 08:50

    From Labs to Leadership: A Vision for Carbon-Neutral Pharma Operations

    • Presenter:

      

      Phil Duncanson, PhD
      Senior Director, Global Quality Control, AstraZeneca

  • 08:50 – 09:30

    Q&A
• 09:00 – 16:15

  Exhibit Hall Open

  Oasis Hall 3-4

• 09:30 – 10:30

  Networking Break in the Exhibit Hall (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 09:30 – 10:30

    Poster Showcase and Voting
  • 09:45 – 10:15

    Meet the Presenters | P1: From Manufacturing Excellence to Patient Impact: The Future of GLP-1 Therapies

    • Presenter:

      

      Lucia M. Novak, MSN, ANP-BC, BC-ADM
      President, Diabesity, LLC

    • Presenter:

      

      Lorraine O'Shea, MS
      Small Molecule and Peptide Plant Manager, Eli Lilly and Company

    • Presenter:

      

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

  • 09:45 – 10:15

    Technical Report Live | Points to Consider No. 11: Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production
• 09:30 – 11:00

  PDA Press Conference

  Mesquite G

• 10:30 – 12:00

  A2: Data Management and Lifecycle Strategies for Advanced Therapies (Primrose A)

  Primrose A

  • Moderator:

    

    Divyang Patel
    Project Manager, AtkinsRéalis

  This session will examine cutting-edge approaches to data management and lifecycle strategies in ATMP and biopharmaceutical manufacturing. Topics will include optimizing digital ecosystems for patient traceability, transitioning from batch to campaign filling modes, and leveraging pharmaceutical continuous manufacturing (PCM) for lifecycle management. Attendees will gain insights into integrating data-driven strategies with regulatory frameworks to enhance efficiency, compliance, and scalability.

  • 10:30 – 10:50

    A Concept for Optimized Digital Data Management: What is Required to Make the ATMP Industry Ready for the Future

    • Presenter:

      

      Judith Koliwer, PhD
      Senior Industry Advisor & Principal Consultant Advanced Therapies, Körber Pharma Software

  • 10:50 – 11:10

    Transitioning from Batch to Campaign Filling Mode – Walking Before Running, APS Qualifications, and Other Considerations

    • Presenter:

      

      Aidan J. Harrington, PhD
      Principal Consultant, Arcadis

  • 11:10 – 11:30

    PCM – An Agile Risk and Data-Driven Lifecycle Management Approach

    • Presenter:

      

      Margarida Ventura, MS
      Quality Risk Management Senior Consultant, ValGenesis

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  B2: Advancing Quality Control: Automated Visual Inspection in Parenterals (Primrose B)

  Primrose B

  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  This session will explore cutting-edge advancements in automated visual inspection (AVI) for parenterals. Topics will include lifecycle and risk management for visible particles, reducing false rejects using data analytics and machine learning (ML), and a novel human-inspired inspection approach. Attendees will leave this session with enhanced knowledge of improving accuracy, efficiency, and compliance in AVI systems.

  • 10:30 – 10:50

    Lifecycle and Risk Management for Visible Particles in Parenterals - Industry Best Practices

    • Presenter:

      

      Antonio Burazer
      Global Head Visual Inspection & Particle LCM, Takeda

  • 10:50 – 11:10

    Enhancing AVI Accuracy: Reducing False Reject by Distinguishing Air Bubbles from Defects Using Data Analysis and ML

    • Presenter:

      

      Berwald Gomes, MSc
      Vision Engineer/Engineer Optical Control, Roche

  • 11:10 – 11:30

    Human-Inspired AVI: The Next Level of Parenteral Packaging Quality Control

    • Presenter:

      

      Chiara Sinito, PhD
      Head of AVI, WILCO AG

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  C2: Digital Transformation (Primrose C)

  Primrose C

  • Moderator:

    

    Malav Parikh, ME
    Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

  This session will delve into the impact of digital transformation on biopharmaceutical processes, highlighting innovations in contamination control, risk management in fill-finish, and streamlining technology transfers. Experts will discuss how digital tools are driving efficiency, reducing risk, and ensuring compliance across the manufacturing lifecycle.

  • 10:30 – 10:50

    Digitalization Strategies for Contamination Control Under Annex 1

    • Presenter:

      

      Sheba S. Zaman
      Head of Product Specialists and Training Services, Novatek

  • 10:50 – 11:10

    QRM and QbD in Fill-Finish: Measure Risk Reduction Scientifically

    • Presenter:

      

      Sebastian Scheler, MSc
      Managing Director, Innerspace

  • 11:10 – 11:30

    A Digital Transformation Path for Better Technology Transfers

    • Presenter:

      

      Yowvanaraj Gopal
      Director Professional Services, ValGenesis

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  D2: Regulatory Insights and Challenges: Annex 1, PUPSIT, and Drug Compounding (Primrose D)

  Primrose D

  • Moderator:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  This session will address key regulatory challenges impacting the pharmaceutical industry. Topics will include insights from the Kilmer Community PUPSIT survey post-Annex 1 implementation, the evolving regulatory framework for compounded drugs, and findings from the PDA Annex 1 survey. Attendees will gain a deeper understanding of regulatory trends, compliance strategies, and their implications for patient safety.

  • 10:30 – 10:50

    PDA Annex 1 Survey

    • Presenter:

      

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

  • 10:50 – 11:10

    Does the Current Visual Inspection Regulatory Framework Ensure the Safety of Compounded Drugs?

    • Presenter:

      

      Vivian Nguyen
      Quality Visual Inspection Manager (Corporate), QuVa Pharma

  • 11:10 – 11:30

    Results Summary of the PDA PUPSIT Survey

    • Presenter:

      

      Maik W. Jornitz
      Principal Consultant, BioProcess Resources

  • 11:30 – 12:00

    Q&A
• 12:00 – 13:30

  Networking Lunch in the Exhibit Hall (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 12:00 – 13:30

    Poster Presentations and Voting
  • 12:30 – 13:00

    Technical Report Live | PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods
• 12:15 – 12:55

  Exhibitor Tech Talks (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 12:15 – 12:25

    Navigating USP <382>: Ensuring Compliance and Safety in Pharmaceutical Packaging with Aptar Pharma

    • Tech Talk Presenter:

      

      Arnaud Fournier
      Regional Market Development Manager, Aptar Pharma

  • 12:30 – 12:40

    EZ-Fill Smart™: Advancing Sustainable RTU Packaging

    • Tech Talk Presenter:

      

      Mitchell J. Brasher
      Global Product Manager, Gerresheimer

  • 12:45 – 12:55

    Defect Detection Lifecycle Approach

    • Tech Talk Presenter:

      

      Karen Granzow
      Senior Consultant, Koerber Pharma, North America

• 13:30 – 14:15

  IG01: Combination Products

  Primrose A

  • Interest Group Leader:

    

    Maggie Bandel, MBA
    Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

• 13:30 – 14:15

  IG02: Drug Compounding

  Primrose C

  • Interest Group Leader:

    

    Arie Anahory, MS
    Global Head of Operations, Regulatory Compliance Associates Inc.

  • Interest Group Leader:

    

    David Short
    Chief Quality Officer, QuVa Pharma

• 13:30 – 14:15

  IG03: Management of Outsourced Operations and Technology Transfer

  Primrose D

  • Interest Group Leader:

    

    Maria Amaya, PhD
    Lead External Advocacy North America (Quality Policy), Genentech

  • Interest Group Leader:

    

    Morten Munk
    Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

  • Interest Group Leader:

    

    Mirko Gabriele, PhD
    CEO, InfiniteVision

  • Interest Group Leader:

    

    Elizabeth Kramer, PhD
    Senior Director, Eli Lilly and Company

• 13:30 – 14:15

  IG04: Quality Risk Management and Supply Chain Management

  Primrose B

  • Interest Group Leader:

    

    Amanda McFarland, MS
    Senior Consultant, ValSource, Inc.

  • Interest Group Leader:

    

    Malav Parikh, ME
    Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

  • Interest Group Leader:

    

    Henry Ames, MBA
    General Manager, Logistics Orchestration, TraceLink

• 13:30 – 15:30

  Mini-Training Course 1: Lyophilization (Ticket Required)

  Mesquite A

  • Instructor:

    

    Nathaniel Milton, PhD, RPh
    Professor of Practice - Industrial and Physical Pharmacy, Purdue University

  This mini-training course will help participants gain an understanding of the basic principles and practical aspects of lyophilization technology. Attendees will learn about the process and equipment, vacuum technology use for freeze drying, solidification during freezing, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics, and process scale-up to production.
• 14:15 – 14:30

  Transition to Next Interest Group

• 14:30 – 15:15

  IG05: Data Governance, Management, Integrity, and Digitalization

  Primrose A

  • Interest Group Leader:

    

    Kir F. Henrici
    Chief Executive Officer, The Henrici Group

  • Interest Group Leader:

    

    Ulrich Koellisch, PhD
    Partner, GxP-CC

• 14:30 – 15:15

  IG06: Microbiology/Environmental Monitoring

  Primrose D

  • Interest Group Leader:

    

    Kurt Jaecques, MA
    Global Quality Technical Senior Lead, GSK

  • Interest Group Leader:

    

    Kim Sobien, MBA
    Senior Consultant - Microbiology, ValSource, Inc.

• 14:30 – 15:15

  IG07: Process Validation

  Primrose C

  • Interest Group Leader:

    

    Robert Dream
    Managing Director, HDR Company

  • Interest Group Leader:

    

    Mauro Giusti, MSc
    Senior Director, Parenteral Technical Knowledge, Eli Lilly and Company

• 14:30 – 15:15

  IG08: Sterile Processing/Parenteral Drug Manufacturing

  Primrose B

  • Interest Group Leader:

    

    Julian Petersen
    Head of Business Development, Groninger

• 14:30 – 15:15

  Lightning Session 1 (Mesquite B)

  Mesquite B

  • Moderator:

    

    Ken Paddock
    Director, Global Quality Sterility Assurance, Merz Aesthetics

  PDA's Lightning Presentations will use the Pecha Kucha presentation method, which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of 6 minutes and 40 seconds.

  • 14:30 – 14:35

    Session Introduction
  • 14:35 – 14:42

    A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters.

    • Presenter:

      

      Yvonne Groß, Dipl.-Ing
      Senior Scientist, Sartorius Stedim Biotech

  • 14:42 – 14:49

    Successful In Situ Disinfectant Field Trials

    • Presenter:

      

      Dan A. Klein, MA
      Senior Technical Service Manager, STERIS

  • 14:49 – 14:56

    Smart Manufacturing with Intelligent Sensors

    • Presenter:

      

      Bethany Silva
      Industry Manager - Life Sciences, Endress+Hauser

  • 14:56 – 15:15

    Q&A
• 15:15 – 16:15

  Networking Break in the Exhibit Hall (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 15:15 – 16:15

    Poster Presentations and Voting
  • 15:30 – 15:50

    Technical Report Live | Enhancing Quality Management Maturity through Data-Driven Insights and Organizational Factors Shaping Quality Culture by KGI
  • 15:30 – 16:00

    Book Signing and Meet the Authors | Quality Risk Management: A Practical Guide

    • Author:

      

      Amanda McFarland, MS
      Senior Consultant, ValSource, Inc.

    • Author:

      

      James L. Vesper, PhD, MPH
      Director, Learning Solutions, ValSource, Inc.

• 16:15 – 17:45

  A3: CMC Insights for Biosimilars and Container Closure Integrity Testing Advancements (Primrose A)

  Primrose A

  • Moderator:

    

    Sebastian B Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  This session will explore key aspects of CMC for biosimilars, including clone selection, manufacturing processes, and comparative assessments. It will address upcoming challenges in container closure integrity testing (CCIT) for low-temperature containers, biopharmaceutical compatibility, and delivery systems. Attendees will also learn about future innovations in CCIT and automated visual inspection (AVI) integration for automated, high-throughput inspection of low-volume solutions.

  • 16:15 – 16:35

    Key CMC considerations for Biosimilar Success

    • Presenter:

      

      Kurt A. Brorson, PhD
      Vice President Technical, PAREXEL

  • 16:35 – 16:55

    Vial Containment and Syringe Systems for Low Temperature Applications

    • Presenter:

      

      Page McAndrew, PhD
      Director, Scientific Communications, West Pharmaceutical Services, Inc.

  • 16:55 – 17:15

    A Novel Approach for CCIT and AVI of Fusion-Sealed Pre-Filled Syringes (PFS) with Opaque Suspensions

    • Presenter:

      

      Matthias Kahl
      Head of R&D and Lab Services, WILCO AG

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  B3: Transforming Contamination Control: Innovative Strategies, Technologies, and Risk Management (Primrose B)

  Primrose B

  • Moderator:

    

    Vanessa Vasadi Figueroa, MA
    Chief Microbiologist, VVF Science

  Contamination control remains critical to pharmaceutical manufacturing, with innovations and methodologies aimed at addressing regulatory compliance challenges and enhancing operational efficiency. This session will delve into real-time microbial monitoring using biofluorescence particle counters, environmental control and monitoring driven by quality risk management (QRM), and approaches to modernizing legacy systems through process modeling and AI-enabled automation. Each presenter will provide actionable insights and practical strategies for contamination control optimization.

  • 16:15 – 16:35

    Real-World Challenges – and Solutions – for the Use of Biofluorescence Particle Counters in Grade A Aseptic Filling Applications

    • Presenter:

      

      Manny Khera
      Head of Engineering - Aseptic Filling, Cytiva

  • 16:35 – 16:55

    Innovative Approaches to Environmental Risk Assessment and Sample Site Selection: Leveraging QRM for Effective Contamination Control

    • Presenter:

      

      Virginia Andreotti-Jones
      Consultant, Quality Risk Management, ValSource, Inc.

  • 16:55 – 17:15

    Improving Legacy Processes: A Case Study on Reducing Risks and Ensuring Regulatory Compliance

    • Presenter:

      

      Jeffrey Gensler
      VP Quality, Kindeva Drug Delivery

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  C3: Applied Artificial Intelligence (Primrose C)

  Primrose C

  • Moderator:

    

    Peter J. Makowenskyj, MEng
    Director of Design Consulting, G-CON

  Over the past decade, artificial intelligence (AI) has seen exponential growth throughout various industries. While we have seen a slower adoption rate in the biopharmaceutical industry, we are coming to an inflection point. In this session, participants will look at the different ways AI is being implemented in our industry within our current regulations.

  • 16:15 – 16:35

    Large Language Models in GMP - Risk Management and Validation

    • Presenter:

      

      Ulrich Koellisch, PhD
      Partner, GxP-CC

  • 16:35 – 16:55

    Quality Inspection Methods for DIP Products According to Pharmacopoeia Annex I and the Benefits of Implementing AI Technology within Traditional Algorithms

    • Presenter:

      

      Gianmarco Pincelli
      Technical Sales Manager, Bonfiglioli Engineering

  • 16:55 – 07:15

    AI-Driven Holistic Risk Management: Transforming Pharma Supply Chains

    • Presenter:

      

      Fabrizio Maniglio
      Industry and Business Development Director, Honeywell

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  D3: Proactive Data, Quality, and Risk Management for Business Sustainability (Primrose D)

  Primrose D

  • Moderator:

    

    Jennifer Cheung
    VP of Global Quality Assurance Operations, Gilead Sciences

  This session will explore the power of proactive data, quality, and risk management to achieve business sustainability in the pharmaceutical industry. Topics will include developing data and risk management driven strategies for supply chain resilience, leveraging quality risk management to achieve operational excellence and business growth, and utilizing advanced graph-based intelligence for quality assurance to increase business competitiveness. Attendees will gain actionable insights into aligning quality processes with business success and sustainability.

  • 16:15 – 16:35

    Data and Risk Management Challenges in the Evolving Drug Supply Chain

    • Presenter:

      

      Kellen Giroux, CQA, CQE
      Director, Quality Solutions, Network Partners Group

  • 16:35 – 16:55

    Quality Risks are Business Risks: Integrating QRM for Strategic Success

    • Presenter:

      

      Lori Richter, PhD
      Sr. Director, GxP Quality Management Systems, ALX Oncology

  • 16:55 – 17:15

    From Compliance to Competitiveness: The Power of Graph-Based Intelligence in Quality Assurance

    • Presenter:

      

      Mike Salem, MA
      Associate Director of Data Science - Quality Assurance, Gilead Sciences

  • 17:15 – 17:45

    Q&A
• 16:30 – 18:30

  PDA Member Lounge Open

  Santa Rosa (Renaissance)

  The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.
• 18:00 – 19:30

  Supplier Think Tank: Aizon (Free for PDA Week Attendees - Advance Sign Up Required)

  Be part of a dynamic discussion where suppliers, innovators, and experts unite to explore strategies, trends, and solutions that matter most. Let’s shape the future of our industry—together.
• 18:00 – 20:30

  Architecture and Celebrity Homes Bicycle Tour (Ticket Required)

  Departs from Renaissance Lobby

  Riders will get a unique glimpse into Palm Springs’ Hollywood history, architectural masterpieces, and destination highlights. The biking route includes the historic Palm Springs neighborhoods where riders will see examples of key architects important to the development of Palm Springs in the 1950s and 1960s as well as several celebrity homes.

  Bicycles and helmets (required) will be provided.

• 18:15 – 20:00

  Bar Trivia + Local Beer Tasting and Dinner (Ticket Required)

  Departs from Renaissance Lobby

  La Quinta Brewing Co. opened their doors in the fall of 2013 and has become a destination spot with continued growth in popularity. Participants will be broken up into teams for rounds of trivia. In between trivia, participants will enjoy a delicious taco/nacho bar with chicken, beef, and vegetarian options with their choice of four (4) different 5 oz beers to taste from La Quinta Brewing Co.’s rotating selection of IPAs, porters, lagers, ales, wheat, and special seasonal beers. A docent will be present to walk you through the beer tastings. Don’t miss your opportunity to enjoy the laid-back desert lifestyle of Palm Springs while sipping craft beer with friends!

  • Price: $70 per person – includes trivia, beer flight, and taco/nacho bar
  • Tickets: 40 max.
  • Start: 18:15 PT – participants to meet in the Renaissance hotel lobby to walk to brewery together (approx. 0.8 m/1.3 km) – group will depart from the hotel lobby promptly at 18:30 PT
  • End: 20:00 PT – participants can return to their hotels at their leisure
  • Note: All participants must be at least 21 years old. Comfortable shoes and a light layer are recommended.
• 18:15 – 20:30

  Palm Springs Aerial Tram and Dinner (Ticket Required)

  Departs from Renaissance Lobby

  The Palm Springs Aerial Tramway has the world’s largest rotating tram car and travels over 2.5 mi/4 km along the cliffs of Chino Canyon, transporting visitors to the pristine wilderness of the Mt. San Jacinto State Park and Wilderness Area. During the 10-min journey, tram cars rotate slowly, offering spectacular views of the valley below. At the tram’s Mountain Station (elevation 8,516 ft/2,596 m and 30°F cooler than the desert floor), guests will enjoy 180-degree views of the valley from the observation decks, watch two documentary films, visit the natural history museum, and enjoy dinner at Peaks Restaurant. This trek to the top of this famous mountain is truly a singular experience!

  Dinner includes your choice of an appetizer, an entrée with two sides, and a soft drink or water. Alcohol is available for purchase.

  • Price: $180 per person – includes tram ticket, dinner, and roundtrip transportation
  • Tickets: 50 max.
  • Start: 18:15 PT – participants to meet in the Renaissance hotel lobby to board the bus that will depart promptly at 18:30 PT
  • End: 21:30 PT – participants will ride the bus back to the Renaissance hotel
  • Note: The temperature at the Mountain Station can be up to 30°F cooler than in the valley, so a jacket and comfortable walking shoes are recommended. Participants will select from the following menu options:
    • Appetizers
      • Charred shrimp
      • Mediterranean bruschetta
    • Entrées
      • Pan Seared Salmon served with mango salsa, jasmine rice, and baby bok choy
      • Wild Mushroom Ravioli in a porcini cream sauce
      • Roasted half duck served with jasmine rice, baby bok choy, and blackberry gastrique
      • Filet of beef in a demi glaze served with red bliss potato puree and baby carrots
• 18:30 – 20:30

  Wine and Watercolors (Ticket Required)

  San Jacinto (Renaissance)

  Calling all artists for this fun and unique experience! Participants will craft beautiful greeting cards with watercolor paints while enjoying their choice of two (2) drinks (wine or beer) and a charcuterie board to snack on. Professional instruction and all supplies to make four (4) greeting cards per person will be provided (cards, pens, paints, brushes, and aprons).

  • Price: $110 per person – includes two (2) glasses of wine or beer, charcuterie, professional watercolor painting instruction, and supplies
  • Tickets: 50 max.
  • Start: 18:30 PT – event will take place at the Renaissance hotel
  • End: 20:30 PT
  • Note: All participants must be at least 21 years old.

PDT Daylight Time (UTC -7:00)

• 06:00 – 06:30

  Morning Wellness Walk

  Departs from Renaissance Lobby

  Rise and refresh!

  Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

  Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

• 06:30 – 07:30

  PDA Member Lounge Open

  Santa Rosa (Renaissance)

  The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.
• 07:00 – 07:45

  FDA Complete Response Letters – A Growing Industry Challenge with Big Impacts (Primrose A)

  Primrose A

  • Moderator:

    

    Glenn E. Wright, MA
    President and CEO, PDA

  This session will discuss the current challenge facing the industry related to manufacturing and facility related Complete Response Letters (CRLs). CRLs are issued at the end of the FDA review cycle for regulatory submission indicating that the submission (BLA/NDA) cannot be approved in its current form. Over the past several years the number of manufacturing and facility related CRLs has greatly increased, creating unprecedented challenges for the industry. This session will provide an update on the current issues and discuss the work being done by PDA on this topic area as well as work being done on behalf of PDA to better understand these CRLs and any predictors of which the industry should be aware.

  • 07:00 – 07:25

    Unpacking FDA CRLs: Manufacturing Hurdles and Industry Response

    • Presenter:

      

      Glenn E. Wright, MA
      President and CEO, PDA

    • Presenter:

      

      Michael de la Torre
      CEO, Redica Systems

  • 07:25 – 07:45

    Q&A with Additional Panelists

    • Panelist:

      

      Andrew C. Chang, PhD
      Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Novo Nordisk

    • Panelist:

      

      Ghada N. Haddad, PhD
      Executive Director, Global Quality Transformation, Merck & Co., Inc.

    • Panelist:

      

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

• 07:00 – 08:00

  Continental Breakfast

  Lobby

• 07:00 – 15:30

  Registration Open

  Oasis Hall 2

• 07:30 – 10:30

  Presenter Ready Pavilion Open

  Oasis Hall 2

• 08:00 – 09:30

  A4: Ensuring Quality and Potency in ATMP Manufacturing (Primrose A)

  Primrose A

  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  This session will explore strategies for maintaining quality and potency in advanced therapy medicinal products (ATMPs). Topics will include developing science-based potency assays, implementing end-to-end product stewardship with modular technologies, and designing robust disinfectant validation programs for cleanrooms. Attendees will gain a deeper understanding of the unique challenges of ATMP production and compliance.

  • 08:00 – 08:20

    Potency Assurance for ATMPs

    • Presenter:

      

      Andrew C. Chang, PhD
      Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Novo Nordisk

  • 08:20 – 08:40

    A New Paradigm of Quality: ATMPs and Product Stewardship

    • Presenter:

      

      Josh Russell
      Vice President of Sales & Marketing, AST

  • 08:40 – 09:00

    Designing a Disinfectant Validation Program for ATMP Cleanrooms

    • Presenter:

      

      Jim N. Polarine, MA
      Principal Consultant, STERIS

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  B4: Primary Packaging (Primrose B)

  Primrose B

  • Moderator:

    

    Robin Usselman
    Sr. Business Development Manager, USA & Canada, PBL (Performing Beyond Limits)

  • 08:00 – 08:20

    Vial to Pre-Filled Syringe: Navigating Drug Product Development and Manufacturing - A Comprehensive Case Study

    • Presenter:

      

      Adithya Balasubramanian, MS
      Director, ten23 health

  • 08:20 – 08:40

    Primary Packaging Compliance: Regulatory Updates and Annex 1 Implementation Case Study

    • Presenter:

      

      Colleen O'Brien, MS
      Strategy and Technical Affairs, Gerresheimer

  • 08:40 – 09:00

    Case Study: Saturated Steam as an Alternative Sterilization Process to EtO for RTF Primary Containers

    • Presenter:

      

      Darren Beckett
      Sr. Training and Technology Center Manager, Fedegari Technologies, Inc.

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  C4: Quality Risk Management (Primrose C)

  Primrose C

  • Moderator:

    

    Kate Malachowski, PhD
    Director, MS&T, Novavax

  This session will provide a blueprint for advancing quality risk management (QRM) practices in the biopharmaceutical industry, including strategies for developing skilled risk assessment facilitators and optimized portfolios. It will also explore the evolving regulatory landscape for AI applications and associated risks. Participants will gain insights into improving risk management processes and navigating emerging industry challenges.

  • 08:00 – 08:20

    Regulations for AI Application: Do We Need More?

    • Presenter:

      

      Stephan K. Roenninger, Dr.-Ing.
      Director Compliance, External Affairs, Amgen

  • 08:20 – 08:40

    Developing Qualified Risk Assessment Facilitators at Takeda

    • Presenter:

      

      Joseph Horvath, PhD
      Head, Global Quality Risk Management, Takeda

  • 08:40 – 09:00

    Developing an Optimized Risk Assessment Portfolio—The QRM Master Plan

    • Presenter:

      

      Kelly Waldron, PhD
      Business Unit Manager, Quality and Manufacturing Science Consulting, ValSource, Inc.

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  D4: Innovative Technologies for Sterility Assurance and Aseptic Processing (Primrose D)

  Primrose D

  • Moderator:

    

    Sebastian B Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  This session will explore cutting-edge technologies and methodologies for achieving sterility assurance in pharmaceutical manufacturing. Topics will include new guidelines for RABS system design and operation, risk evaluation for transitioning to X-ray sterilization of single-use systems, and the benefits of low-energy electron beam technology for pharmaceutical packaging sterilization. Attendees will gain insights into advancing sterility assurance while addressing regulatory and sustainability challenges.

  • 08:00 – 08:20

    Sterility Assurance – Meeting an Unmet Industry Technical Need on Design and Operation of RABS Systems

    • Presenter:

      

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

  • 08:20 – 08:40

    Evaluating Risks in Implementing X-Ray Sterilization for Single-Use Systems

    • Presenter:

      

      Samuel Dorey, PhD
      Principal Scientist Materials & Irradiation, Sartorius Stedim Biotech

  • 08:40 – 09:00

    Low Energy Electron Beams for the Sterilisation of Pharmaceutical Packaging

    • Presenter:

      

      Thomas Kroc, PhD
      US Representative, International Irradiation Association

  • 09:00 – 09:30

    Q&A
• 09:00 – 13:45

  Exhibit Hall Open

  Oasis Hall 3-4

• 09:30 – 10:30

  Networking Break in the Exhibit Hall (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 09:30 – 10:30

    Poster Presentations
  • 09:45 – 10:15

    Book Signing and Meet the Authors | Quality Risk Management: A Practical Guide

    • Author:

      

      Amanda McFarland, MS
      Senior Consultant, ValSource, Inc.

    • Author:

      

      James L. Vesper, PhD, MPH
      Director, Learning Solutions, ValSource, Inc.

  • 09:45 – 10:15

    Meet the Presenters | P2: Sustainability at Scale: Transforming Facilities and Mindsets in Pharma

    • Presenter:

      

      Phil Duncanson, PhD
      Senior Director, Global Quality Control, AstraZeneca

    • Presenter:

      

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

  • 09:45 – 10:15

    Technical Report Live | ANSI/PDA Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
• 10:30 – 11:15

  IG09: Advanced Manufacturing and Applied Process Digitalization

  Primrose D

  • Interest Group Leader:

    

    Peter J. Makowenskyj, MEng
    Director of Design Consulting, G-CON

  • Interest Group Leader:

    

    Toni Manzano
    Co-Founder and CSO, Aizon

• 10:30 – 11:15

  IG10: ATMP

  Primrose A

  • Interest Group Leader:

    

    Rebecca D. Jordan
    Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb

• 10:30 – 11:15

  IG11: Facilities and Engineering

  Primrose C

  • Interest Group Leader:

    

    Shelley M. Preslar, MBA
    CEO/Principal SME, Panacea Group

• 10:30 – 11:15

  IG12: Quality Systems

  Primrose B

  • Interest Group Leader:

    

    Ghada N. Haddad, PhD
    Executive Director, Global Quality Transformation, Merck & Co., Inc.

  • Interest Group Leader:

    

    Michele Simone
    Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco

  • Interest Group Leader:

    

    Eva M. Urban, MSc
    Senior Director, Risk Management, Bristol Myers Squibb

• 10:30 – 12:30

  Mini-Training Course 2: Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat (Ticket Required)

  Mesquite A

  • Instructor:

    

    Michael J. Sadowski
    Owner, Sterilexcellence

  This mini-training course will benefit organizations that are pursuing development of a parametric release moist heat sterilization program as well as organizations seeking to improve conventional moist heat sterilization programs. This lecture and discussion mini-training course will provide an introduction and overview of parametric release.
• 11:15 – 11:30

  Transition to Next Interest Group

• 11:30 – 12:15

  IG13: Annex 1 Implementation

  Primrose B

  • Interest Group Leader:

    

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

  • Interest Group Leader:

    

    Stephen E. Langille, PhD
    Senior Microbiology Consultant, ValSource, Inc.

• 11:30 – 12:15

  IG14: Filtration

  Primrose D

  • Interest Group Leader:

    

    Maik W. Jornitz
    Principal Consultant, BioProcess Resources

  • Interest Group Leader:

    

    William Peterson
    Director, Global QA, Merck & Co., Inc.

• 11:30 – 12:15

  IG15: Vaccines

  Primrose A

  • Interest Group Leader:

    

    Cristiana Campa, PhD
    Technical R&D Advisor, GSK

  • Interest Group Leader:

    

    Sabrina Restrepo, PhD
    Executive Director - Quality Assurance, Merck & Co., Inc.

• 11:30 – 12:15

  Lightning Session 2 (Mesquite B)

  Mesquite B

  • Moderator:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  PDA's Lightning Presentations will use the Pecha Kucha presentation method, which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of 6 minutes and 40 seconds.

  • 11:30 – 11:35

    Session Introduction
  • 11:35 – 11:42

    The Generated Pre-Trained Transformer Parallels Project: A Practical Method for Generative AI Integration into Workforce Development and Biomanufacturing Research and Manufacturing

    • Presenter:

      

      Richard Jaenisch, MPH
      Director of Education and Outreach, Open Biopharma Research and Training Institute

  • 11:42 – 11:49

    Particle Loss in Tubing During Airborne Particle Counting

    • Presenter:

      

      Michael J. Dingle
      Senior Product Specialist, TSI

  • 11:49 – 11:56

    Lean Approach to Analytical Panels to Support Cleaning Validation

    • Presenter:

      

      Brian Bosso
      Technical Service Manager, STERIS

  • 11:56 – 12:15

    Q&A
• 11:30 – 12:15

  PDA Journal of Pharmaceutical Science and Technology—The Members' Journal (Primrose C)

  Primrose C

  • Moderator:

    

    Walter Morris
    Senior Director, Publishing, PDA

  In this session, participants will learn about the latest content published in the 79-year-old, peer-reviewed PDA Journal of Pharmaceutical Science and Technology (JPST), including updates on the new submission and reviewer site as well as the new reviewer management and recognition program. Hear from the winning authors (invited) of the 2024 Frederick Simon D. Simon Paper of the Year Award. All current and potentially interested authors and reviewers are especially invited to attend.

  • 11:30 – 12:00

    Editor's Perspective

    • Presenter:

      

      Shanker Gupta, PhD
      Editor-In-Chief, PDA Journal of Pharmaceutical Science and Technology

  • 12:00 – 12:15

    Q&A
• 12:15 – 13:45

  Networking Lunch in the Exhibit Hall (Oasis Hall 3-4)

  Oasis Hall 3-4

  • 12:15 – 13:45

    Passport Drawing
  • 12:15 – 13:45

    Poster Awards and Presentations
  • 12:30 – 13:00

    Technical Report Live | PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
• 13:45 – 15:15

  P3: From Burnout to Breakthrough: Inspiring Person-Centered Care (Oasis Hall 1)

  Oasis Hall 1

  • Moderator:

    

    Kate Malachowski, PhD
    Director, MS&T, Novavax

  Every healthcare professional has a crucial impact on person-centered care – including those who do not have direct patient contact. By specifically recognizing the ways that their work is directly tied to a human being, Allison will generate a deeper connection to the patient experience for each participant. This closing plenary session will address how fostering a culture of compassion, engagement, and innovation can combat burnout and create breakthroughs in patient-centered care. Participants will leave with a renewed sense of purpose, empowered by the knowledge that their contributions improve patient outcomes, enhance company culture, and drive both personal and organizational success.

  • 13:45 – 14:30

    From Burnout to Breakthrough: Inspiring Person-Centered Care

    • Presenter:

      

      Allison Massari, MFA
      Burn Survivor, Patient-Advocate, and Interdisciplinary Artist, allisonmassari.com

  • 14:30 – 15:00

    Q&A
  • 15:00 – 15:15

    Closing Remarks from the PDA Week 2025 Co-Chairs

    • Co-Chair:

      

      Kate Malachowski, PhD
      Director, MS&T, Novavax

    • Co-Chair:

      

      Susan J. Schniepp
      Distinguished Fellow, Regulatory Compliance Associates Inc.

• 15:15 – 15:45

  Meet the Presenter | P3: From Burnout to Breakthrough: Inspiring Person-Centered Care (Oasis Hall 1)

  Oasis Hall 1

  • Presenter:

    

    Allison Massari, MFA
    Burn Survivor, Patient-Advocate, and Interdisciplinary Artist, allisonmassari.com

• 15:30 – 17:00

  Supplier Think Tank: Alliance for RTU (Free for PDA Week Attendees - Advance Sign Up Required)

  Be part of a dynamic discussion where suppliers, innovators, and experts unite to explore strategies, trends, and solutions that matter most. Let’s shape the future of our industry—together.

  Join the Alliance for RTU as they present, "Collaborating to Innovate: Advancing Quality and Efficiency with Ready-To-Use Vials and Cartridges." This Supplier Think Tank will explore how implementing a ready-to-use (RTU) industrial setup can streamline processes, lower contamination risks, and reduce the total cost of ownership. After hearing from pharma and contract manufacturing organization (CMO) industry experts, participants will have a chance to provide valuable user input through an interactive discussion.

  • Introduction and Opening Speech | Mr. Richard Johnson, Immediate Past President and CEO, PDA
  • Strategic Advantages to Use RTU Containers as Primary Packaging Platform for Bio Drugs: The Perspective of a BioPharma | Mr. Victor Bradford, Director PSDPE Drug Product, Regeneron
  • Flexibility and Speed to Market While Preserving High-End Quality in Pharma Fill&Finish Operations: The Perspective of a CDMO | Mrs. Mihaela Carmen Simian, Vice President of R&D and Operations, Singota Solutions
  • RTU Packaging Benefits and Cost Savings in Pharma Fill&Finish Operations: The Perspective of a CDMO | Mr. Dhaval Patel, Director MS&T, INCOG BioPharma Services, Inc.

  By signing up for this Think Tank, participants understand that their contact information will be shared with the Alliance for RTU founding members (Gerresheimer, Schott Pharma, Stevanato Group).

  Alliance for RTU Think Tank Sign Up—Free for PDA Week Attendees

• 15:30 – 17:30

  PDA Member Lounge Open

  Santa Rosa (Renaissance)

  The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.
• 15:45 – 17:45

  Mini-Training Course 3: Introduction to RABS and Isolators (Ticket Required)

  Mesquite A

  • Instructor:

    

    Anne Weeks
    Senior Commercial Applications Expert, MilliporeSigma

  This mini-training course will provide practical insights into the design, installation, and operation of barrier technology, specifically isolators. Participants will learn some basics about isolator design, operational requirements, cleaning and decontamination methods, and validation of isolators.
• 18:00 – 21:30

  Taste of the Desert Epicurean Tour (Ticket Required)

  Departs from Renaissance Lobby

  Your "foodie" guides will introduce you to the Palm Springs Valley as you venture on foot (approx. 1.5 m/2.4 km) to locally owned restaurants to taste varied culinary delights. Between tastings, you will learn about the art, history, and culture of the area and some unique facts about each of the restaurants. With so much happening in Downtown Palm Springs, this tour offers an insiders’ take on the diverse culinary and cultural offerings of this famous destination.

  Sample Tour Menu - Restaurants and menus to be confirmed in early March 2025

  • Tommy Bahama: Coconut Shrimp, Chicken Mango Salad, Mai Tai
  • Maracas: Variety of Street Tacos, Chips, Salsa, Margarita
  • Tutti Frutti: Date Shake and Fresh Fruit Frozen Yogurt Samples
  • Bill’s Pizza: Award-Winning 4 cheese Pizza on Sourdough Crust
  • Brandini Toffee: Toffee and Popcorn Tastings, Take Home Sample
  • Lulu California Bistro: Signature Triple Chocolate Cake

PDT Daylight Time (UTC -7:00)

• 06:00 – 06:30

  Morning Wellness Walk

  Departs from Renaissance Lobby

  Rise and refresh!

  Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

  Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

• 07:00 – 08:30

  PDA D/A/CH Chapter: Opportunities and Challenges for Start Ups Webinar

  Santa Rosa (Renaissance)

  Join the PDA D/A/CH Chapter Thursday, 10 April for coffee and connections at PDA Week 2025! Gather in person to watch the Chapter’s Opportunities and Challenges for Start Ups webinar live, then stay to network and exchange ideas with fellow professionals. All PDA members, regardless of chapter, are welcome! Coffee and tea will be provided—please sign up in advance.

  • Where: PDA Member Lounge at the Renaissance Hotel
  • When: Thursday, 10 April, 07:00-08:30 PDT
  • Cost: Free!
  • Attend In Person at PDA Week 2025: Advance Sign Up

  Join us for an engaging conversation where we will explore three captivating stories of innovation in biotechnology and IT. Are you aware of the key differences between launching a new business idea in the biotech or IT sectors in the USA and Germany?

  Discover the contrasting approaches to launching new business ideas in Germany and the USA. Whether you choose to join us online or attend in person at PDA Week 2025 in Palm Springs, CA, this is a conversation you won't want to miss.

  Meet the Presenters

  • Lara Denk, a Master's student in Economics at Ludwig Maximilian University (LMU) in Munich, will present insights on this topic.
  • Bianca Bohrer, CEO of PSM, a German CDMO, will discuss her experiences setting up a new Contract Development and Manufacturing Organization (CDMO) service that provides a comprehensive range of solutions from API to sterile pharmaceutical products, including the hurdles she faced.
  • Svetlana Kiseleva, CPO and Co-Founder of Plair SA will introduce new technologies for manufacturing sterile medicines, specifically focusing on a Biofluorescent Particle Counter (BFPC) that aims to replace traditional monitoring methods using settle plates.

  The webinar will conclude with an interactive session discussing how the PDA D/A/CH Chapter can support startups and accelerate the adoption of innovative technologies in the market.

  We look forward to seeing you there!

• 07:00 – 16:00

  PDA Member Lounge Open

  Santa Rosa (Renaissance)

  The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.
• 07:30 – 16:00

  Registration Open

  San Jacinto (Renaissance)

• 08:30 – 16:00

  Aseptic Processing Essentials Workshop - Separate Registration Required (Pueblo - Renaissance)

  Pueblo (Renaissance)

  • Instructor:

    

    Hal Baseman, MBA
    Vice President, ValSource, Inc.

  This workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The workshop will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

  Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

  Workshop Information and Registration

• 08:30 – 16:00

  Contamination Control Strategy Essentials Workshop - Separate Registration Required (Chino - Renaissance)

  Chino (Renaissance)

  • Instructor:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  Learn not only the theory of developing a great contamination control strategy (CCS), but also how to translate that theory into actual practice. Gain the skills you need to create holistic contamination control strategies covering all aspects of the manufacturing operation, including facility design and utilities, environmental control, validation and monitoring, quality systems, people, and processes.

  This workshop is based on the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing, which will be provided free to each participant as a tool to prepare for the workshop. Jumpstart your CCS understanding and how to apply it to your manufacturing facilities and processes in this world-class interactive workshop – your hands-on solution to developing and implementing a successful CCS!

  Workshop Information and Registration

PDT Daylight Time (UTC -7:00)

• 07:30 – 16:30

  Registration Open

  San Jacinto (Renaissance)

• 08:30 – 16:30

  Fundamentals of Quality Risk Management Training Course - Separate Registration Required (Chino - Renaissance)

  Chino (Renaissance)

  • Instructor:

    

    Virginia Andreotti-Jones
    Consultant, Quality Risk Management, ValSource, Inc.

  • Instructor:

    

    Tiffany A. Baker, MBA
    Senior Consultant, ValSource, Inc.

  This training course will provide an overview of the quality risk management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

  This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

  Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

  Training Course Information and Registration