PDA GMP Comparison Workshop 2024

Wednesday, 11 September EDT

• 12:00 – 17:30

  Registration Open
• 16:00 – 17:30

  P1: How to Compare Global Sterile Manufacturing Regulations

  • Moderator: Joseph C. Frantz, MS, PhD, Consultant

    

    Joseph C. Frantz, MS, PhD, Consultant
    

    Dr. Frantz is a recognized expert in Sterility Assurance (SA) with over 4 decades of experience in R/D, manufacture, and QA of vaccines for humans and animals. Joe’s industrial career includes SmithKline Animal Health, Pfizer Animal Health and Sanofi Pasteur. At Sanofi, Joe led multifunctional teams on development and validation of sterile manufacture of human vaccines. Additionally, Joe joined Global Quality Assurance as the Global Head of SA. In this role, Joe led the Sanofi Pasteur Center of Excellence for SA and Co-Led of the Sanofi Community of Practice for Contamination Control and Sterility Assurance. The Sanofi CoP oversaw company-wide evaluation, revision, and publication of sterile manufacturing Quality policies. Joe’s responsibilities also included Global Business System Owner for Environmental Monitoring and continuous improvement through implementation of Global sterile manufacturing policies.
    
    Dr. Frantz holds a MS and PhD in Medical Microbiology and Immunology from the University of Oklahoma Health Sciences Center and completed a post-doctoral fellowship at the University of Kansas in structure and function of bacterial enterotoxins. In addition, he is a retired Naval Officer (Surface Warfare) and proudly served in uniform, active and reserve, for 31 years. Dr. Frantz is now active as a sterility assurance consultant.

  Join us for an immersive session demonstrating how to leverage PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison (2024). Learn practical strategies and approaches for leveraging PDA’s comparison tool in achieving regulatory compliance and the potential competitive edge of understanding and addressing regulatory challenges. The expert presenters will reveal the mindset of regulators and share insights into their priorities and concerns, including the limited focus on the global market and the emphasis on local laws and regulations.

  • 16:00 – 16:15

    Welcome and Opening Remarks from Workshop Chair

    • Chair: Joseph C. Frantz, MS, PhD, Consultant

      

      Joseph C. Frantz, MS, PhD, Consultant
      

      Dr. Frantz is a recognized expert in Sterility Assurance (SA) with over 4 decades of experience in R/D, manufacture, and QA of vaccines for humans and animals. Joe’s industrial career includes SmithKline Animal Health, Pfizer Animal Health and Sanofi Pasteur. At Sanofi, Joe led multifunctional teams on development and validation of sterile manufacture of human vaccines. Additionally, Joe joined Global Quality Assurance as the Global Head of SA. In this role, Joe led the Sanofi Pasteur Center of Excellence for SA and Co-Led of the Sanofi Community of Practice for Contamination Control and Sterility Assurance. The Sanofi CoP oversaw company-wide evaluation, revision, and publication of sterile manufacturing Quality policies. Joe’s responsibilities also included Global Business System Owner for Environmental Monitoring and continuous improvement through implementation of Global sterile manufacturing policies.
      
      Dr. Frantz holds a MS and PhD in Medical Microbiology and Immunology from the University of Oklahoma Health Sciences Center and completed a post-doctoral fellowship at the University of Kansas in structure and function of bacterial enterotoxins. In addition, he is a retired Naval Officer (Surface Warfare) and proudly served in uniform, active and reserve, for 31 years. Dr. Frantz is now active as a sterility assurance consultant.

  • 16:15 – 16:35

    Seeing the Challenge and Charting the Course

    • Presenter: Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA

      

      Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA
      

      Josh Eaton joined PDA in 2011 as a project manager and is now Senior Director, Scientific and Regulatory Affairs at PDA. He and his team work with PDA members to produce Technical Reports, Points to Consider documents, and feedback on regulatory draft guidance. The S&RA staff also facilitate the activities of the PDA Technical Advisory Boards and PDA Interest Groups. Prior to joining PDA, Josh developed and marketed drug discovery and research reagents and co-founded a small spin-off company based on those technologies. He earned his Master’s degree in Biochemistry and Biotechnology in 2005 from Georgetown University.

  • 16:35 – 16:55

    Navigating Regulatory Minds: Strategies and Practices for Compliance

    • Presenter: Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.

      

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

      Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a BS degree in Biology from the University of Massachusetts and a PhDin Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection Expert Panel and serves on several PDA task forces related to microbiological product quality.

  • 16:55 – 17:30

    Q&A
• 17:30 – 18:30

  Networking Reception in the Exhibit Area

Thursday, 12 September EDT

• 08:00 – 09:00

  Continental Breakfast
• 08:00 – 17:00

  Registration Open
• 09:00 – 10:30

  P2: Using the Comparison to (Re-)Design a Training Program

  • Moderator: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

    

    Christine Sherman, Global Sterility Assurance & Microbiology, Takeda
    

    Christine Sherman is a member of the Takeda Global Sterility Assurance & Microbiology team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing at the sterile manufacturing sites. Her newest assignment is implementing a Sterility Assurance program at Takeda's sites in Japan. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, cell therapies, and vaccines. Prior to joining Takeda in 2017, she worked for Johnson & Johnson, Pfizer in the QC microbiology department, and later, at Merck in a Sterility Assurance role for the Durham, NC vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental and utility monitoring programs, process simulation of bulk and finished product, airflow visualization studies, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. She has experience supporting Microbiological investigations for environmental and utility monitoring, sterile and non-sterile products, and process simulation positives. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently active in PDA Technical Report revisions and a member of the South East Chapter.

  A robust training program is critical to ensuring manufacturing staff compliance, however, the design and maintenance of training programs tend to be an afterthought. Gaps in the training of both new and experienced staff include missing references to applicable guidelines, no explanation as to the “why” behind the instruction, and insufficient or lack of training for certain tasks are common. Get an introduction on how to use the comparison document to ensure your training programs are in alignment with Health Authorities and general best practices. Case studies and small group working sessions will illustrate some commonly found gaps in training programs and offer practical experience using the comparison document to identify and remediate them.

  • 09:00 – 09:20

    Building a Solid Foundation by Optimizing Your Training Program

    • Presenter: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

      

      Amanda Curtis, Microbiology Consultant, ValSource, Inc.
      

      Amanda Curtis is a Microbiology Consultant at ValSource with 15 years of experience in medical microbiology, pharmaceutical microbiology, and other regulated industries. She received her bachelor’s degree in Microbiology from Purdue University. Amanda’s pharmaceutical expertise is in the field of Advanced Therapy Medicinal Products (ATMPs), with experience bringing cell and gene therapy products through FDA Pre-Approval Inspections. She is experienced in complex investigations, sterility testing, and microbial and contamination control with a focus on risk-based approaches to environmental monitoring.

  • 09:20 – 10:05

    Designing a Compliant Aseptic Process Simulation (APS): Small Group Work

    • Presenter: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

      

      Amanda Curtis, Microbiology Consultant, ValSource, Inc.
      

      Amanda Curtis is a Microbiology Consultant at ValSource with 15 years of experience in medical microbiology, pharmaceutical microbiology, and other regulated industries. She received her bachelor’s degree in Microbiology from Purdue University. Amanda’s pharmaceutical expertise is in the field of Advanced Therapy Medicinal Products (ATMPs), with experience bringing cell and gene therapy products through FDA Pre-Approval Inspections. She is experienced in complex investigations, sterility testing, and microbial and contamination control with a focus on risk-based approaches to environmental monitoring.

  • 10:05 – 10:30

    Report Out and Discussion
• 10:30 – 11:00

  Networking Break in the Exhibit Area
• 11:00 – 12:30

  P3: Significant Misalignment of Sterile Manufacturing Guidances

  • Moderator: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

    

    Amanda Curtis, Microbiology Consultant, ValSource, Inc.
    

    Amanda Curtis is a Microbiology Consultant at ValSource with 15 years of experience in medical microbiology, pharmaceutical microbiology, and other regulated industries. She received her bachelor’s degree in Microbiology from Purdue University. Amanda’s pharmaceutical expertise is in the field of Advanced Therapy Medicinal Products (ATMPs), with experience bringing cell and gene therapy products through FDA Pre-Approval Inspections. She is experienced in complex investigations, sterility testing, and microbial and contamination control with a focus on risk-based approaches to environmental monitoring.

  The Global Sterile Manufacturing Regulatory Guidance Comparison analyzes seven international sterile manufacturing guidances. Although many requirements and expectations are aligned across these documents, there are differences that exist. In some cases, these differences are vernacular or theoretical, while others are significant. And to make it more challenging, some health authorities require additional measures that are not a part of other sterile manufacturing guidelines. In this session, we will identify and discuss significant misalignments of the seven sterile manufacturing guidances. We also provide an opportunity for industry peers to discuss mitigation strategies and communication approaches for regulatory documents and inspections.

  • 11:00 – 11:15

    Understanding the Differences of Sterile Manufacturing Guidance for Personnel, Training, and Qualification

    • Presenter: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

      

      Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb
      

      Nidhi Shah has 30+ years of experience in the Pharma/ Biotech/Cell Therapy industry. She is a result-oriented leader with extensive knowledge of Business, management, and operations in the industry. She is a resourceful and innovative leader with a broad knowledge of Operations and Quality Control. Nidhi graduated with an EMBA in Business Administration and Management and has her BS degree in Microbiology/Chemistry. She is certified in Managing Clean Rooms and Controlled Environments, and in Medical Laboratory Technology. Nidhi is Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb. She has represented USA as a Delegate for revision of ISO 14644-5. She has participated in successful audits of health authorities from around the world. Nidhi has served as planning committee for CCS workshop and has served as the panelists in same. In addition, she is an Executive Board Member for ISPE NJ chapter. She is on planning committee for ISPE Global ISPE Aseptic Conference and serves as a liaison and a panelist for Women In Pharma. “I am always curious for learning new. As once said by Mahatma Gandhi: 'Live as if you were to die tomorrow and Learn as if you were to live forever.'”

  • 11:15 – 11:30

    Manufacturing Facilities and Equipment: The Old, the New, and the Challenging

    • Presenter: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

      

      Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.
      

      Brian Bell is Sr. Director at Amgen leading the Cellular Sciences team within Process Development, Attribute Sciences. Cellular Sciences is responsible for adventitious agent control strategies including viral clearance study execution, mycoplasma testing for clinical programs, assay evaluation and development for bioburden, endotoxin, sterility, and viral contaminates, production, qualification, and management of critical reagents, and authoring, review, and responding to health authority inquiries on adventitious agent control and methods for regulatory documents. Brian earned a PhD in Biomedical Research from The Ohio State University studying microbial pathogenesis. Prior to working in the pharmaceutical industry, Brian researched biothreat agents for government and industrial clients.

  • 11:30 – 12:15

    Hands-On Exercise Addressing Challenges in Implementing International Sterile Guidance

    • Presenter: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

      

      Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.
      

      Brian Bell is Sr. Director at Amgen leading the Cellular Sciences team within Process Development, Attribute Sciences. Cellular Sciences is responsible for adventitious agent control strategies including viral clearance study execution, mycoplasma testing for clinical programs, assay evaluation and development for bioburden, endotoxin, sterility, and viral contaminates, production, qualification, and management of critical reagents, and authoring, review, and responding to health authority inquiries on adventitious agent control and methods for regulatory documents. Brian earned a PhD in Biomedical Research from The Ohio State University studying microbial pathogenesis. Prior to working in the pharmaceutical industry, Brian researched biothreat agents for government and industrial clients.

    • Presenter: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

      

      Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb
      

      Nidhi Shah has 30+ years of experience in the Pharma/ Biotech/Cell Therapy industry. She is a result-oriented leader with extensive knowledge of Business, management, and operations in the industry. She is a resourceful and innovative leader with a broad knowledge of Operations and Quality Control. Nidhi graduated with an EMBA in Business Administration and Management and has her BS degree in Microbiology/Chemistry. She is certified in Managing Clean Rooms and Controlled Environments, and in Medical Laboratory Technology. Nidhi is Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb. She has represented USA as a Delegate for revision of ISO 14644-5. She has participated in successful audits of health authorities from around the world. Nidhi has served as planning committee for CCS workshop and has served as the panelists in same. In addition, she is an Executive Board Member for ISPE NJ chapter. She is on planning committee for ISPE Global ISPE Aseptic Conference and serves as a liaison and a panelist for Women In Pharma. “I am always curious for learning new. As once said by Mahatma Gandhi: 'Live as if you were to die tomorrow and Learn as if you were to live forever.'”

  • 12:15 – 12:30

    Report Out and Discussion
• 12:30 – 13:30

  Networking Lunch in the Exhibit Area
• 13:30 – 15:00

  P4: Effective Strategies for Comprehensive Gap Assessments

  • Moderator: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

    

    Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.
    

    Brian Bell is Sr. Director at Amgen leading the Cellular Sciences team within Process Development, Attribute Sciences. Cellular Sciences is responsible for adventitious agent control strategies including viral clearance study execution, mycoplasma testing for clinical programs, assay evaluation and development for bioburden, endotoxin, sterility, and viral contaminates, production, qualification, and management of critical reagents, and authoring, review, and responding to health authority inquiries on adventitious agent control and methods for regulatory documents. Brian earned a PhD in Biomedical Research from The Ohio State University studying microbial pathogenesis. Prior to working in the pharmaceutical industry, Brian researched biothreat agents for government and industrial clients.

  Do you dread the task of completing a gap assessment against a regulatory document or internal Standard Operating Procedure? You’re not alone! Many of us have faced the overwhelming challenge of this assignment. Join this session to learn how to conduct a comprehensive gap assessment for your facilities without feeling like you’d rather be at the dentist. Through hands-on exercises, we’ll explore the essential components of effective gap assessments and what they should not entail.

  • 13:30 – 13:40

    Congratulations! You Have Volunteered to Complete a Gap Assessment

    • Presenter: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

      

      Christine Sherman, Global Sterility Assurance & Microbiology, Takeda
      

      Christine Sherman is a member of the Takeda Global Sterility Assurance & Microbiology team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing at the sterile manufacturing sites. Her newest assignment is implementing a Sterility Assurance program at Takeda's sites in Japan. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, cell therapies, and vaccines. Prior to joining Takeda in 2017, she worked for Johnson & Johnson, Pfizer in the QC microbiology department, and later, at Merck in a Sterility Assurance role for the Durham, NC vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental and utility monitoring programs, process simulation of bulk and finished product, airflow visualization studies, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. She has experience supporting Microbiological investigations for environmental and utility monitoring, sterile and non-sterile products, and process simulation positives. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently active in PDA Technical Report revisions and a member of the South East Chapter.

  • 13:40 – 14:40

    Finding the Gaps: Hands-On Strategies

    • Presenter: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

      

      Christine Sherman, Global Sterility Assurance & Microbiology, Takeda
      

      Christine Sherman is a member of the Takeda Global Sterility Assurance & Microbiology team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing at the sterile manufacturing sites. Her newest assignment is implementing a Sterility Assurance program at Takeda's sites in Japan. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, cell therapies, and vaccines. Prior to joining Takeda in 2017, she worked for Johnson & Johnson, Pfizer in the QC microbiology department, and later, at Merck in a Sterility Assurance role for the Durham, NC vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental and utility monitoring programs, process simulation of bulk and finished product, airflow visualization studies, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. She has experience supporting Microbiological investigations for environmental and utility monitoring, sterile and non-sterile products, and process simulation positives. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently active in PDA Technical Report revisions and a member of the South East Chapter.

  • 14:40 – 15:00

    Report Out and Discussion
• 15:00 – 15:30

  Networking Break in the Exhibit Area
• 15:30 – 17:00

  P5: The Impact of Quality Management Systems on Business Operations

  • Moderator: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

    

    Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb
    

    Nidhi Shah has 30+ years of experience in the Pharma/ Biotech/Cell Therapy industry. She is a result-oriented leader with extensive knowledge of Business, management, and operations in the industry. She is a resourceful and innovative leader with a broad knowledge of Operations and Quality Control. Nidhi graduated with an EMBA in Business Administration and Management and has her BS degree in Microbiology/Chemistry. She is certified in Managing Clean Rooms and Controlled Environments, and in Medical Laboratory Technology. Nidhi is Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb. She has represented USA as a Delegate for revision of ISO 14644-5. She has participated in successful audits of health authorities from around the world. Nidhi has served as planning committee for CCS workshop and has served as the panelists in same. In addition, she is an Executive Board Member for ISPE NJ chapter. She is on planning committee for ISPE Global ISPE Aseptic Conference and serves as a liaison and a panelist for Women In Pharma. “I am always curious for learning new. As once said by Mahatma Gandhi: 'Live as if you were to die tomorrow and Learn as if you were to live forever.'”

  A comprehensive quality management system holds significant potential to harmonize business operations with regulatory requirements, leading to efficient solutions that enhance overall quality in a cost-effective manner. In this session, a case study will serve as a practical example showcasing an effective approach. Engage in role-playing exercises that simulate the process of presenting these strategies to senior management for approval. Don’t miss the opportunity to gain actionable insights to apply in your own professional settings!

  • 15:40 – 16:30

    Creating a Simplified Value Stream Map: Small Group Work

    • Presenter: Joseph C. Frantz, MS, PhD, Consultant

      

      Joseph C. Frantz, MS, PhD, Consultant
      

      Dr. Frantz is a recognized expert in Sterility Assurance (SA) with over 4 decades of experience in R/D, manufacture, and QA of vaccines for humans and animals. Joe’s industrial career includes SmithKline Animal Health, Pfizer Animal Health and Sanofi Pasteur. At Sanofi, Joe led multifunctional teams on development and validation of sterile manufacture of human vaccines. Additionally, Joe joined Global Quality Assurance as the Global Head of SA. In this role, Joe led the Sanofi Pasteur Center of Excellence for SA and Co-Led of the Sanofi Community of Practice for Contamination Control and Sterility Assurance. The Sanofi CoP oversaw company-wide evaluation, revision, and publication of sterile manufacturing Quality policies. Joe’s responsibilities also included Global Business System Owner for Environmental Monitoring and continuous improvement through implementation of Global sterile manufacturing policies.
      
      Dr. Frantz holds a MS and PhD in Medical Microbiology and Immunology from the University of Oklahoma Health Sciences Center and completed a post-doctoral fellowship at the University of Kansas in structure and function of bacterial enterotoxins. In addition, he is a retired Naval Officer (Surface Warfare) and proudly served in uniform, active and reserve, for 31 years. Dr. Frantz is now active as a sterility assurance consultant.

  • 16:30 – 16:55

    Group Discussion: How to Have Effective Communication with Senior Management
  • 16:55 – 17:00

    Closing Remarks from Workshop Chair

    • Chair: Joseph C. Frantz, MS, PhD, Consultant

      

      Joseph C. Frantz, MS, PhD, Consultant
      

      Dr. Frantz is a recognized expert in Sterility Assurance (SA) with over 4 decades of experience in R/D, manufacture, and QA of vaccines for humans and animals. Joe’s industrial career includes SmithKline Animal Health, Pfizer Animal Health and Sanofi Pasteur. At Sanofi, Joe led multifunctional teams on development and validation of sterile manufacture of human vaccines. Additionally, Joe joined Global Quality Assurance as the Global Head of SA. In this role, Joe led the Sanofi Pasteur Center of Excellence for SA and Co-Led of the Sanofi Community of Practice for Contamination Control and Sterility Assurance. The Sanofi CoP oversaw company-wide evaluation, revision, and publication of sterile manufacturing Quality policies. Joe’s responsibilities also included Global Business System Owner for Environmental Monitoring and continuous improvement through implementation of Global sterile manufacturing policies.
      
      Dr. Frantz holds a MS and PhD in Medical Microbiology and Immunology from the University of Oklahoma Health Sciences Center and completed a post-doctoral fellowship at the University of Kansas in structure and function of bacterial enterotoxins. In addition, he is a retired Naval Officer (Surface Warfare) and proudly served in uniform, active and reserve, for 31 years. Dr. Frantz is now active as a sterility assurance consultant.

Posters