PDA Global Sterile Manufacturing Regulatory Guidance Comparison Workshop 2024
A One-Stop-Shop for Global Aseptic Processing Expectations
Registration Options
Individual Registration
Group Registration
Calling on all professionals and teams who are involved with the manufacture of aseptically filled sterile drug products for markets around the world.
Attending PDA’s new Global Sterile Manufacturing Regulatory Guidance Comparison Workshop is critical for navigating an extremely complex regulatory environment.
The workshop, based on PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book (newly revised for release in fall 2024) and its updated comparison toolset, brings forward the regulations and information you need to ensure the compliance of your aseptic filling operations with Good Manufacturing Practice (GMP) for all major market countries and regions.
Even if you were one of the 5,000 individuals who purchased and used PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book published in 2016, you know expectations around the world continue to change. Keeping pace with the global regulatory requirements can be overwhelming for anyone. This update fills a much-needed gap in simplifying the challenging task of looking across regulatory guidances to ensure global compliance.
It is a professional imperative that you attend the workshop.
Why Attend?
The necessity to meet the requirements for where products are manufactured as well as where they are sold can confound the most experienced professionals and teams.
Keeping track of so many variations and ensuring compliance of manufacturing activities is an absolute must for international pharmaceutical manufacturing professionals and the companies they represent.
The newly-revised PDA Global Sterile Manufacturing Regulatory Guidance Comparison Book (2024), and associated comparison toolset presents similarities and differences in guidelines for aseptic processing from seven GMP guidances: U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan.
You receive not only immersion in the updated book content but will immediately learn how to use the comparison tool set (used by pharma manufacturing professionals around the world) to help identify gaps that may exist in your current operations and hear directly from the industry experts who literally wrote the book.
What You Gain
- You receive an early release copy of the book* and all of its tools and supporting documents (at no additional charge). This is a valuable resource to have in your hands to facilitate alignment across regions before the book is released to the industry!
- A two-day engaging, educational and practical workshop with hands-on experiences filled with practical real-world advice to ensure understanding and appropriate manufacturing compliance.
- Immediate application of new knowledge and understanding via facilitated and group-led discussions, case studies, and role-playing exercises.
- Industry expert presentations on Good Manufacturing Practice (GMP) specific to aseptic processing in these best practice areas:
- How to perform a gap assessment in global aseptic processing requirements.
- How to master internal assessment of sterile manufacturing.
- How to inform decision-making when considering future investments.
- How to apply PDA’s comparison tool to ensure your training programs are in alignment with Health Authorities’ expectations and industry best practices.
- How to consider the impact of quality management systems on business operations.
- How to identify and discuss significant misalignments of the seven major sterile manufacturing guidances.
Attend the workshop to learn from PDA’s industry experts and your peers and become informed and empowered about sterile manufacturing regulations and compliance from U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan.
*PDA will release the revised Global Sterile Manufacturing Regulatory Guidance Comparison book to the industry and public for purchase in October 2024.
PROGRAM PLANNING COMMITTEE
- Joseph Frantz, Retired (Chair)
- Brian Bell, Amgen Inc.
- Amanda Curtis, ValSource, Inc.
- Nidhi Shah, Bristol Myers Squibb
- Christine Sherman, Takeda
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
Training Course Inquiries
Registration Customer Care
Early Registration
Register by 17 July 2024
Member Price
$1,595GovernmentMember Only
$895
Health AuthorityMember Only
$895
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$895
Non-Member
$1,995
Standard Registration
Register after 17 July 2024
Member Price
$2,095GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$2,395
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 registration@pda.org.
Wednesday, 11 September EDT
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Registration Open
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P1: How to Compare Global Sterile Manufacturing Regulations
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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.
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Welcome and Opening Remarks from Workshop Chair
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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.
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Seeing the Challenge and Charting the Course
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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.
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Navigating Regulatory Minds: Strategies and Practices for Compliance
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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.
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Q&A
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Networking Reception in the Exhibit Area
Thursday, 12 September EDT
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Continental Breakfast
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Registration Open
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P2: Using the Comparison to (Re-)Design a Training Program
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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.
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Building a Solid Foundation by Optimizing Your Training Program
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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.
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Designing a Compliant Aseptic Process Simulation (APS): Small Group Work
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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.
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Report Out and Discussion
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Networking Break in the Exhibit Area
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P3: Significant Misalignment of Sterile Manufacturing Guidances
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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.
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Understanding the Differences of Sterile Manufacturing Guidance for Personnel, Training, and Qualification
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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.'”
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Manufacturing Facilities and Equipment: The Old, the New, and the Challenging
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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.
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Hands-On Exercise Addressing Challenges in Implementing International Sterile Guidance
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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.'”
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Report Out and Discussion
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Networking Lunch in the Exhibit Area
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P4: Effective Strategies for Comprehensive Gap Assessments
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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.
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Congratulations! You Have Volunteered to Complete a Gap Assessment
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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.
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Finding the Gaps: Hands-On Strategies
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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.
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Report Out and Discussion
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Networking Break in the Exhibit Area
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P5: The Impact of Quality Management Systems on Business Operations
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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.'”
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Creating a Simplified Value Stream Map: Small Group Work
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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.
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Group Discussion: How to Have Effective Communication with Senior Management
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Closing Remarks from Workshop Chair
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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.
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Presenters
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Brian L. Bell, PhD
Senior Director Cellular Sciences, Amgen Inc.
Committee Member
Moderator
Presenter
Read Bio
Brian L. Bell, PhD
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. -
Amanda Curtis
Microbiology Consultant, ValSource, Inc.
Committee Member
Moderator
Presenter
Read Bio
Amanda Curtis
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. -
Josh Eaton, MS
Senior Director, Scientific and Regulatory Affairs, PDA
Presenter
Read Bio
Josh Eaton, MS
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. -
Joseph C. Frantz, MS, PhD
Consultant
Chair
Moderator
Presenter
Read Bio
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. -
Stephen E. Langille, PhD
Senior Microbiology Consultant, ValSource, Inc.
Presenter
Read Bio
Stephen E. Langille, PhD
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. -
Nidhi Shah, MBA
Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb
Committee Member
Moderator
Presenter
Read Bio
Nidhi Shah, MBA
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.'” -
Christine Sherman
Global Sterility Assurance & Microbiology, Takeda
Committee Member
Moderator
Presenter
Read Bio
Christine Sherman
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.
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Westin Washington, DC Downtown
999 9th Street, NWWashington, DC 20001, United States
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.
Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to CityCenterDC, the best of the city awaits outside the doors. Unwind in the inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.
Additional Hotel Information
- Rate: $331 plus applicable taxes and fees (currently 15.95%)
- Cut-Off Date: Friday, 09 August 2024