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  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 11/20/2024 at 2:00 PM (EST)

    This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.

    Description:  This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.




    Kip J. Hanks

    Director of Regulatory and Governmental Affairs

    After earning a BS in microbiology from McNeese State University and finishing up 6 years as a special operations forward air controller in the Louisiana Air National Guard, Kip Hanks began employment with the FDA as a field investigator in 1997. After a few years as a generalist covering multiple FDA-regulated products, he became a district biologics specialist and then the Office of Regulatory Affairs (ORA) biologics national expert. In this role, Kip was responsible for providing regulatory and guidance interpretation and application to ORA staff, training and mentoring new investigators, serving on policy and document workgroups and advising ORA senior leadership on biologics-related matters. In July 2021, he joined the American Association of Tissue Banks as its first director of regulatory and governmental affairs. In this role, Kip establishes and communicates the AATB official position regarding regulatory issues that may impact AATB member organizations to the FDA and other applicable governmental and standard-setting organizations. He provides expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members.

    Tricia Samaniego Martinez

    Senior Advisor

    US Food & Drug Administration

    Tricia Samaniego Martinez currently serves as a Senior Advisor for the Office of Biologics Inspectorate (OBI), Immediate Office, within the Office of Inspections and Investigations at the US Food and Drug Administration. After receiving her Bachelor of Science in Microbiology from Texas A&M University, she joined the FDA as an Investigator. She has worked in the Houston and San Antonio offices conducting inspections and investigations in the Biologics, Human and Animal Drug, and Bioresearch Monitoring programs, in both the domestic and foreign arenas.

    Tricia most recently served as the Division Director of Investigations where she was responsible for leading a team of managers and investigators, primarily located in the western half of the US, during a time of quickly evolving technologies in the biologics industry. The staff under her management conducted inspections and investigations of establishments handling biological products, including blood and blood components, Source Plasma, and human cell, tissue, and cellular based tissue products.
    As a Senior Advisor, she is responsible for working directly with OBI management, as well as cross-organizational leadership in developing, recommending, and coordinating operational priorities, activities and resources to ensure consistency and optimization throughout the program. In addition, she is responsible for advising OBI leadership on emerging and precedent-setting issues, representing OBI on Agency level work groups and leading multiple trainings.

  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 11/20/2024 at 2:00 PM (EST)

    This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.

    Description:  This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.


    Target Audience: This webinar is designed for tissue bank professionals with interest in birth tissue.



    Kip J. Hanks

    Director of Regulatory and Governmental Affairs

    After earning a BS in microbiology from McNeese State University and finishing up 6 years as a special operations forward air controller in the Louisiana Air National Guard, Kip Hanks began employment with the FDA as a field investigator in 1997. After a few years as a generalist covering multiple FDA-regulated products, he became a district biologics specialist and then the Office of Regulatory Affairs (ORA) biologics national expert. In this role, Kip was responsible for providing regulatory and guidance interpretation and application to ORA staff, training and mentoring new investigators, serving on policy and document workgroups and advising ORA senior leadership on biologics-related matters. In July 2021, he joined the American Association of Tissue Banks as its first director of regulatory and governmental affairs. In this role, Kip establishes and communicates the AATB official position regarding regulatory issues that may impact AATB member organizations to the FDA and other applicable governmental and standard-setting organizations. He provides expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members.

    Tricia Samaniego Martinez

    Senior Advisor

    US Food & Drug Administration

    Tricia Samaniego Martinez currently serves as a Senior Advisor for the Office of Biologics Inspectorate (OBI), Immediate Office, within the Office of Inspections and Investigations at the US Food and Drug Administration. After receiving her Bachelor of Science in Microbiology from Texas A&M University, she joined the FDA as an Investigator. She has worked in the Houston and San Antonio offices conducting inspections and investigations in the Biologics, Human and Animal Drug, and Bioresearch Monitoring programs, in both the domestic and foreign arenas.

    Tricia most recently served as the Division Director of Investigations where she was responsible for leading a team of managers and investigators, primarily located in the western half of the US, during a time of quickly evolving technologies in the biologics industry. The staff under her management conducted inspections and investigations of establishments handling biological products, including blood and blood components, Source Plasma, and human cell, tissue, and cellular based tissue products.
    As a Senior Advisor, she is responsible for working directly with OBI management, as well as cross-organizational leadership in developing, recommending, and coordinating operational priorities, activities and resources to ensure consistency and optimization throughout the program. In addition, she is responsible for advising OBI leadership on emerging and precedent-setting issues, representing OBI on Agency level work groups and leading multiple trainings.

  • Contains 13 Product(s)

    Browse AATB's free webinars.

    Browse AATB's free webinars. 

  • Contains 202 Product(s)

    Save your staff time and money when you take advantage of the AATB Group Webinar Series Subscription. With one registration, your entire company will gain access to all AATB webinar programming for the whole year.

    The 2024 AATB Webinar Series subscription includes:

    Unlimited company-wide access to 30+ live webinars

    Unlimited company-wide access to an additional 160+ on-demand webinars

    Unlimited company-wide access to all AATB asynchronous module-based programs, such as the "AATB Online Auditor Course" and "Grief and Loss: Defining Concepts and Supporting the Bereaved"  

    Educational credits, including CTBS, CEBT, RN, and more!

    Webinar topics include regulatory updates, surgical application, donor screening, and so much more. All program content has been developed to support the tissue community's diverse roles and experience levels.

  • Contains 201 Product(s)

    Take advantage of the AATB Individual Webinar Series Subscription providing individual access to an entire year of educational programming.

    Take advantage of the AATB Individual Webinar Series Subscription providing individual access to an entire year of educational programming. 

    The 2024 AATB Webinar Series subscription includes the following:

    ·       Individual access to 30+ live webinars

    ·       Individual access to an additional 160+ on-demand webinars

    ·       Individual access to all AATB asynchronous module-based programs, such as the "AATB Online Auditor Course" and "Grief and Loss: Defining Concepts and Supporting the Bereaved"

    ·       Educational credits, including CTBS, CEBT, RN, and more!

    Webinar topics include regulatory updatessurgical applicationdonor screening, and more. All program content has been developed to support the tissue community's diverse roles and experience levels.

  • Contains 3 Component(s), Includes Credits

    As live donor medical charts are reviewed, certain birth tissue diseases may be encountered. This talk includes a brief introduction to the normal structure of the placenta and umbilical cord. Subsequently, the more common birth tissue abnormalities found in the medical charts will be discussed. The presentation will include many visual images, which are necessary to describe the birth tissue pathology. Donor eligibility and product suitability will be easier to determine with this enhanced knowledge of birth tissue pathology.

    Description: As live donor medical charts are reviewed, certain birth tissue diseases may be encountered. This talk includes a brief introduction to the normal structure of the placenta and umbilical cord. Subsequently, the more common birth tissue abnormalities found in the medical charts will be discussed. The presentation will include many visual images, which are necessary to describe the birth tissue pathology. Donor eligibility and product suitability will be easier to determine with this enhanced knowledge of birth tissue pathology.


    Target Audience: This webinar is designed for tissue bank professionals with interest in birth tissue.



    Andrea Ho, MD

    Associate Medical Director

    AlloSource

    I graduated St. Louis University School of Medicine. My anatomic/clinical pathology residency program was University of Missouri, Kansas City. I completed fellowships in Transfusion Medicine and Cytopathology at the University of Colorado. I have been an Associate Medical Director at AlloSource for approximately 2 1/2 years. I am CTBS certified. I am a member of the AATB Physicians Council and I served on the Monkey Pox Physicians Council Work group.

  • Contains 3 Component(s), Includes Credits

    As live donor medical charts are reviewed, certain birth tissue diseases may be encountered. This talk includes a brief introduction to the normal structure of the placenta and umbilical cord. Subsequently, the more common birth tissue abnormalities found in the medical charts will be discussed. The presentation will include many visual images, which are necessary to describe the birth tissue pathology. Donor eligibility and product suitability will be easier to determine with this enhanced knowledge of birth tissue pathology.

    Description:  As live donor medical charts are reviewed, certain birth tissue diseases may be encountered. This talk includes a brief introduction to the normal structure of the placenta and umbilical cord. Subsequently, the more common birth tissue abnormalities found in the medical charts will be discussed. The presentation will include many visual images, which are necessary to describe the birth tissue pathology. Donor eligibility and product suitability will be easier to determine with this enhanced knowledge of birth tissue pathology.


    Target Audience: This webinar is designed for tissue bank professionals with interest in birth tissue.



    Andrea Ho, MD

    Associate Medical Director

    AlloSource

    I graduated St. Louis University School of Medicine. My anatomic/clinical pathology residency program was University of Missouri, Kansas City. I completed fellowships in Transfusion Medicine and Cytopathology at the University of Colorado. I have been an Associate Medical Director at AlloSource for approximately 2 1/2 years. I am CTBS certified. I am a member of the AATB Physicians Council and I served on the Monkey Pox Physicians Council Work group.

  • Contains 3 Component(s), Includes Credits

    In an ever-evolving workplace landscape, organizations must be proactive in their approach to succession planning and talent management. This webinar will address the critical need for succession planning, explore various approaches, and provide strategies for effective communication. Additionally, we'll discuss how current workplace challenges and employee expectations present opportunities to integrate key components of talent and retention strategies, leverage an Employee Value Proposition (EVP), and foster a thriving organizational culture.

    Description:  In an ever-evolving workplace landscape, organizations must be proactive in their approach to succession planning and talent management. This webinar will address the critical need for succession planning, explore various approaches, and provide strategies for effective communication. Additionally, we'll discuss how current workplace challenges and employee expectations present opportunities to integrate key components of talent and retention strategies, leverage an Employee Value Proposition (EVP), and foster a thriving organizational culture.

    Target Audience: This webinar is designed for tissue bank professionals in management or leadership positions.



    David Staley, SPHR, SCP

    Vice President, Human Resources and Organizational Development

    LifeGift

    David Staley serves as the vice president of human resources and organizational development at LifeGift. He began his career at LifeGift in 2015 after serving as director of human resources at LifeNet Health, based in Virginia Beach, VA. Previously, Staley served as a human resources executive for Fortune 50 companies, privately held organizations and non-profit organizations. He received his undergraduate and graduate degrees from Old Dominion University in Norfolk, VA. Staley has a Senior Professional in Human Resources certification from the Human Resources Certification Institute and is a Senior Certified Professional through the Society for Human Resources Management.

    Laura Walling-Sotolongo, CTBS

    Sr. Director, Talent + Optimization

    As a dynamic executive coach, educator, and transformational change catalyst, Laura Walling-Sotolongo uses her ~20 year experience in various aspects of Tissue Banking including leadership development, performance management, employee training, donor screening, tissue authorization, recovery, processing, distribution, and quality systems to produce impactful bottom-line results. In her current role as the Sr. Director, Talent + Optimization at New England Donor Services, Laura brings high energy, positivity, and consistent results to organizational & talent development, leadership coaching, and learning design.

    She graduated with a Bachelor's of Science in Molecular Biology and is a Lean Six Sigma Green Belt, Gallup Certified Strengths Coach, and CTBS certified.  She is driven by operationalizing strategies with tactics that engage, align, empower, and develop NEDS' employees and leadership team to help them cultivate their strengths and support positive change that maximizes their potential.

  • Contains 3 Component(s), Includes Credits

    This webinar will address the regulatory and scientific considerations for allograft-based bone void filler regulated as devices under FDA's 510(k) pathway in the Center for Devices and Radiological Health (CDRH). Participants will be guided through the 510(k) pathway from product concept to marketing authorization and beyond, including when allograft-based bone void fillers would be considered a device under 510(k), what marketing claims are permissible for these devices, how to identify a predicate, and what types of testing are necessary. The webinar will also include how participants can obtain feedback related to their allograft-based bone void filler and best practices for interacting with FDA.

    Description: This webinar will address the regulatory and scientific considerations for allograft-based bone void filler regulated as devices under FDA's 510(k) pathway in the Center for Devices and Radiological Health (CDRH). Participants will be guided through the 510(k) pathway from product concept to marketing authorization and beyond, including when allograft-based bone void fillers would be considered a device under 510(k), what marketing claims are permissible for these devices, how to identify a predicate, and what types of testing are necessary. The webinar will also include how participants can obtain feedback related to their allograft-based bone void filler and best practices for interacting with FDA.

    Educational Objectives:

    • Identify when a 510(k) is needed for allograft-based bone void fillers.
    • Understand how to select a predicate and the substantial equivalence decision-making.
    • Describe the types of non-clinical and animal performance testing necessary to support a 510(k).
    • Understand best practices when interacting with the Agency.


    Target Audience: This webinar is designed for tissue bank professionals with expertise in QA/QC, regulatory, research, processing and distribution. 



    Laura Rose, PhD

    Engagement Partner

    Bruder Consulting & Venture Group

    Dr. Rose has nearly 8 years of FDA experience and served as the Assistant Director for the Division of Restorative, Repair and Trauma Devices in CDRH’s Office of Orthopedic Devices where she led a large and diverse team of engineers, clinicians, and scientists. She brings a comprehensive understanding of FDA regulations, guidance, and decision-making, as well as a wealth of knowledge about regulation of devices and combination products for tissue engineering and regenerative medicine. She signed multiple Substantial Equivalence (SE) letters for Restorative & Repair orthopedic devices and combination products, including bone void fillers and allograft-based products. Dr. Rose is an Engagement Partner with Bruder Consulting Venture Group (BCVG)

  • Contains 16 Component(s), Includes Credits

    AATB’s Publication-based CE is an enduring activity in which the learner reads one or more publications/articles related to tissue banking from AATB and/or a peer-reviewed professional journals. This activity offers learners opportunities to earn CTBS and CEBT credits.

    AATB Publication-based CE is an enduring activity in which the learner reads one or more publications/articles related to tissue banking from AATB and/or a peer-reviewed professional journals. This activity offers learners opportunities to earn CTBS and CEBT credits.

    Activity Requirements: Each AATB Publication-based activity consists of the full-text publication or article, a post-test quiz, and an activity evaluation. Each Publication-based activity should take 1 hour to complete. CE Certificates are available after the learner scores 75% or more on the activity post-test.

    Target audience: This enduring activity is for all levels of tissue banking professionals with practices in donor screening, tissue recovery and acquisition, family services, quality, regulatory, research, processing, and distribution. 

    CEU: 1 CTBS/CEBT per completed activity.