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2013 Webinar Schedule

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2013 Webinar Schedule

January 23
12pm ET

How to meet GMP's for phase 1 trials
Organized by the NA LRA

February 6
12pm ET

Risk Evaluation Management
Organized by the CC

Febrary 27
12pm ET

Facility Size and Challenges in the Lab: More Volume, More Problems?
Organized by the LPC

March 27
12pm ET

How to always be inspection-ready
Organized by the NA LRA

May 08
9am ET

Validation Requirements for Computerized Systems
Organized by the LPC

June 05
12pm ET

Preclinical PK/PD analysis of cell therapies vs. small molecules
Organized by the CC

June 17
9am ET

ATMP Regulations
Organized by the EU Regional Leadership Committee and EU LRA

July 10
12pm ET

Practical Guide to INDs/IDEs
Organized by the NA LRA

July 24
12pm ET
Postponed and until further notice

Highlights from 2013 Annual Meeting Quality and Operations Track
Organized by the LPC

August 07
12pm ET

Clinical Trials Design End Points
Organized by the CC

September 25
9am ET

TBD
Organized by the EU LRA

October 16/17

9pm ET/6pm PT/9am Western
Australia/ 12 noon Sydney, Australia

Generation of Antigen-Specific T Cells for Allogeneic Stem Cell Transplant
Organized by the AUS/NZ Regional Executive Committee

November 05
12pm ET

ISCT Cost of Goods Survey: Results and Red Flags
Organized by the CC

November 06
12pm ET

Preparing the Lab for a New Clinical Trial
Organized by the LPC

November 13
12pm ET
CliniMACS Prodigy – Mastering the complexity of cell processing
Complimentary Webinar Sponsored by Miltenyi Biotec

November 20
12pm ET

Towards Bioengineered Control of Cell Fate Post Transplantation
Organized by the CC

November 25
12pm ET
Technological Advances in Contamination Testing
Organized by the NA LRA

Key:

LPC - Lab Practices Committee
NA LRA - North America Legal & Regulatory Affairs Committee
CC - Commercialization Committee


Webinar Information

How to meet GMP's for phase 1 trials

Organized by the ISCT North America Legal and Regulatory Affairs Committee

January 23, 2013
12:00pm ET to 1:00pm ET

Chair and Speaker: Debe Griffin, MSc, Quality Assurance Manager for Cellular Therapies, University of Pittsburgh Cancer Institute, USA

Speaker: Angela Pardee, Postdoctoral Associate, Dept. Medicine, University of Pittsburgh, presenting on behalf of Lisa H. Butterfield, Ph.D. Associate Professor of Medicine, Surgery and Immunology Director, UPCI Immunologic Monitoring and Cellular Products Laboratory University of Pittsburgh

Registration (Early Deadline: January 16th; Late Deadline: January 21st):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Goals of the webinar (for the presenters):

  1. Review the FDA Guidance for the statutory GMPs for Phase 1 clinical trials
  2. Discuss changes required whether going from full GMP or from non-GMP processing

Learning objectives (for the participants):

  1. Know where to find statutory GMP and the Guidance
  2. Understand the implications to a facility and its processing/manufacturing
  3. Document the review of the requirements and any changes made to a facility’s process

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Risk Evaluation Management

Organized by the ISCT Commercialization Committee

February 06, 2013
12:00pm ET to 1:00pm ET

Chair: Wouter Van't Hof, PhD, Senior Director of Regenerative Medicine, Athersys, Inc. USA

Speakers: Natalie Mount, PhD, Chief Clinical Officer, Catapult Limited, UK and Karin Hoogendoorn, Janssen Biologics BV, The Netherlands

Registration (Early Deadline January 30th, Late Deadline February 4th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Similar to the path for drugs, the development of cell therapy products (CTP) is a high risk and expensive endeavor. Regulatory expectations, development time and specific challenges for each development stage need to be taken into account. The Target Product Profile (TPP) concept provides an important mechanism for risk management and symbolizes the idea of beginning a development process with the ultimate product in mind. More specifically, as stated in regulatory guidance documents, "the TPP should represent the ideal version of what the sponsor would like to claim for product labeling, and the design, conduct, and analysis of clinical trials to maximize efficiency of program development”. Although commonly implemented for drugs, especially in big pharma, it appears the TPP concept has not yet been widely considered as a disciplined planning approach for CTP development.

At its core, a well-utilized TPP is a communication tool that enhances efficient dialogue at various levels in the organization and through stages of development. This begins with internal program management by sponsors from discovery through development. It extends to discussions between sponsor and regulatory agencies and as such can minimize the risk of gaps in data becoming apparent at a late-stage, impacting overall development time and success. Furthermore, it is adaptable as a framework for discussion between academic discoverers, industrial developers/partnerships and investors.

Functionally, the TPP enables advancement of the various development needs in parallel, integrating R&D, (non)clinical, regulatory, process and manufacturing, quality (QA/QC), commercial, labeling, and marketing needs. The document also incorporates flexibility to address the high likelihood for the need for change during product development, e.g. due to technical difficulties, clinical issues around safety and efficacy, changes in competition, IP landscapes and marketing.
In this webinar we will discuss the TPP concept, the structure and utility of the document with specific emphasis on management of the unique risk profile for CTP development and highlight this by case presentation of the use of TPP in the development of an autologous and an allogeneic CTP.

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Facility Size and Challenges in the Lab: More Volume, More Problems?

Organized by the ISCT Lab Practices Committee

February 27, 2013
12pm ET to 1:00pm ET

Chair: Deborah Lamontagne, B.S.,MLS (ASCP)CM, Cellular Therapy Manager, Florida Hospital Cellular Therapy Laboratory, USA

Speakers: Karl Stasko, MPH, Stem Cell Transplant Lab Supervisor, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA and Heather Hansen, BSc, Cell Processing Technologist, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA

Registration (Early Deadline February 20th, Late Deadline February 25th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

The learning objectives for this webinar are:

  1. Learn different problem solving techniques from three different cellular therapy laboratories.
  2. Understand the impact of laboratory size and staffing on problem solving decision making.
  3. Review accreditation challenges faced by cellular therapy laboratories due to size, staffing and workload.
  4. Review problem solving from a technologist viewpoint versus a supervisory viewpoint.

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How to always be inspection-ready

Organized by the ISCT North America Legal and Regulatory Affairs Committee

March 27, 2013
12pm ET to 1pm ET

Chair:Olive Sturtevant, MSc, Director, Cell Therapy Quality Assurance, Dana Farber Cancer Institute, Massachusetts, USA

Speakers: Olive Sturtevant and Ed Brindle, MSc, MT, Manager, Quality and Regulatory Affairs at Insception Biosciences, Ontario, Canada

About the Webinar:

Are you inspection ready for accrediting or regulatory agencies that might knock on your door?In this ever changing and heavy regulated field of cellular therapy, it is a challenge to keep current with the variety of agencies that inspect and accredit our manufacturing and testing labs. With more and more international clinical trials, many of our labs are subject to inspections from international agencies. Once you understand the focus of each agency assessing, you can better prepared for those encounters. Aside from looking at the basics, this webinar will take a more in-depth look at similarities and differences between US, Canadian and UK agencies. There are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections

Learning Objectives

  • This session will cover the how to prepare for any assessment from an accrediting or regulatory agency
  • Review commonalities and differences in between US, Canadian and UK Inspections and assessments for product manufacturing
  • We will address how to handle sensitive areas and documents depending on the agency involved
  • Address the common deficiencies and findings and how you might avoid them
  • How to make this a good learning experience Given the nature of the field many GCP inspections, particularly those involving FDA investigators, are o useful process for improving quality and ensuring compliance.

Who should attend?

Quality & Regulatory Staff responsible for compliance

Laboratory staff

Managers and Supervisors

Why you should attend

Cell Therapy programs and manufacturers are subject to numerous inspections from a variety of agencies with different areas of focus. This webinar will address common practices to prepare for both the announced and unannounced audits. We will also discuss some of the similarities and difference between US and International inspections and assessments that are common areas focused on for cell therapy manufacturers.

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Validation Requirements for Computerized Systems

Organized by the ISCT Lab Practices Committee

May 8th, 2013
12pm ET to 1:00pm ET

Chair: Karen Snow, BS, (ASCP)BB, CQA(ASQ), Quality Manager, Massachusetts General Hospital, Bone Marrow Transplant Program

Speaker: Andrew Havens, ECL2 Quality Solutions

Registration (Early Deadline May 1st, Late Deadline May 6th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Computerized Systems are becoming more prominent in, and in some cases, an integral part of cellular therapy processes. Quality management Systems, Lab Information Management Systems and Inventory Software are just a few examples. According to 21 CFR 1271.160b.6.d regarding computers, the agency states we must validate the performance of computer software for the intended use when we rely on the system to comply with core cGTP requirements, whether custom designed or commercially available. However, the term "Validation" is open to a wide range of interpretation. How does a facility go about properly validating something as complex as a computerized system?

This webinar will outline a robust and proven method for complete computerized system validation. It will include rationale for validation, discussion on risk assessment, document examples including content, to include requirement and test case examples. This webinar will give attendees a solid foundation from which to design a robust validation process which will withstand FDA inspection scrutiny.

Learning Objectives:

  • Describe why validation of a computer system is essential
  • Examine what is different from a standard process or equipment validation
  • Illustrate components of a robust and inspection resilient Computerized System Validation Plan
  • Evaluate what you need, including specific documents and what they contain
  • Propose risk mitigation strategies to include and test against

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Preclinical PK/PD analysis of cell therapies vs. small molecules

Organized by the ISCT Commercialization Committee

June 5th, 2013
12pm ET to 1pm ET

Chair: Aleks Francki, PhD, Senior Principal Scientist, Celgene Cellular Therapeutics

Speaker(s): TBD

Registration (Early Deadline May 29th, Late Deadline June 3rd):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

 

TBA

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ATMP Regulations

Organized by the ISCT EU Regional Leadership Committee and EU LRA

June 17th, 2013
9am ET to 10am ET

Chair: Stefan Scheding, MD, Lund University, Sweden

Speakers: Martin Hildebrandt, MD, Technische Universität München, Germany and Anne Dickinson, MD, Royal Victoria Infirmary, UK

Registration (Early Deadline June 10th, Late deadline June 13th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

"Advanced Therapy Medicinal Products (ATMPs) are medicinal products of human use, based on gene therapy, somatic cell therapy or tissue engineering. A rapidly growing area in translational research, they represent the "next generation" of complex medicines for complex diseases and pose particular challenges to medicines regulation.

Regulation (EC) No 1394/2007 has been designed to ensure the free movement of ATMPs within the European Union (EU), to facilitate their access to the EU market and to foster the competitiveness of European pharmaceutical companies while guaranteeing the highest level of health protection for patients.

This webinar will provide information on current ATMP regulations with a special focus on ATMPs in academic environments."

Learning Objectives:

1) To learn the basic criteria used to define ATMPs and the challenges inherent in this definition of innovative and complex medicines

2) To become familiar with the classification, certification and marketing authorisation of ATMPs

3) To explore pathways for first-in man applications of ATMPs, including the Hospital Exemption Clause and alternatives

4) To learn about the differences in ATMP regulation implementation in the member states

5) To understand what characteristics are linked with "success" in ATMP production and development in academic environments

6) To learn about academia's perception if and how the ATMP Regulation 1394/2007/EC has hindered innovation

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Practical Guide to INDs/IDEs

Organized by the ISCT NA LRA

July 10th, 2013
12pm ET to 1pm ET

Chair: Bill Janssen, PhD, Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center

Speaker(s): TBD

Registration (Early Deadline July 3rd, Late deadline July 8th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

TBA

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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Highlights from the 2013 Annual Meeting Quality and Operations Track

Organized by the ISCT Lab Practices Committee

July 24, 2013
12pm ET to 1:00pm ET

Chair: Martin Hildebrandt, MD, Head GMP Facility, Technische Universität München

Speaker(s):TBD

Registration (Early Deadline July 17th; Late Deadline July 22nd):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

TBD

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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Clinical Trial Design End Points

Organized by the ISCT Commercialization Committee

August 7th, 2013
12pm ET to 1:00pm ET

Chair:Claudia Zylberberg, PhD, CEO, Akron Biotech

Speaker(s): TBD

Registration (Early Deadline July 31st, Late Deadline August 5th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

TBD

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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TBD

Organized by the ISCT EU Legal and Regulatory Affairs Committee

September 25th, 2013
9am ET to 10:00am ET

Chair:TBD

Speaker(s): TBD

Registration (Early Deadline September 18th, Late Deadline September 23rd):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

TBD

Register Now

Purchase or Access the Recording (FREE for members 3 months post event)

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Generation of Antigen-Specific T Cells for Allogeneic Stem Cell Transplant

Organized by the ISCT AUS/NZ Regional Executive Committee

October 16th/17th, 2013
6:00pm PT, 8:00pm CT, 9:00pm ET/9:00am Western Australia, 12:00pm Sydney, Australia

Chair:Robert Nordon, PhD, Senior Lecturer, Graduate School of Biomedical Engineering, University of New South Wales, Sydney, Australia

Speaker(s): Catherine Bollard, MD, FRCPC, Professor of Pediatrics, Children's National Medical Center, Washington D.C., United States and David Gottlieb, MD, Professor of Haematology, Department of Medicine, Westmead Hospital, Westmead, Australia

Registration (Early Deadline October 9th, Late Deadline October 14th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Donor-derived T cells can expand and reconstitute immunity to infection and tumour antigens when given after stem cell transplant. Viral and fungal infections after allogeneic stem cell transplantation are an important cause of morbidity and mortality and early clinical experience suggests that the severity of these can be reduced by administration of antigen specific T cells. Ex vivo generation of antigen-specific T cells requires careful donor selection and adherence to the code of good manufacturing practice in cell generation. This webinar examines technical and clinical progress in the generation and adoptive transfer of multivalent antigen-specific T cells to allogeneic stem cell transplant recipients.

Learning objectives

1.Clinical role for third party expanded antigen specific T cell.

·Awareness of post-transplant infections that may be targeted using adoptive immunotherapy

·Essential aspects of donor selection and testing prior to attempting to generate antigen specific T cells

2.Technical challenges for generating multivalent antigen specific T cells for clinical trials

·Generating antigen-specific T cells of single or multiple pathogen specificity for clinical administration

·Selection of immunogenic peptides for a multi-tumour antigen-specific T cell product

3.Monitoring and testing of patients who have received antigen specific T cells following allogeneic stem cell transplantation

4.Results of prophylactic and therapeutic adoptive immunotherapy with antigen specific T cells following allogeneic stem cell transplantation

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ISCT Cost of Goods Survey: Results and Red Flags

Organized by the ISCT Commercialization Committee

November 05, 2013
12pm ET to 1:00pm ET

Chair: William Milligan, Chair, ISCT Business Models and COGs Subcommittee

Speaker(s): William Milligan, Robert Perry,, Knut Niss, members, ISCT Business Models and COGs Subcommittee

Registration (Early Deadline October 28th, Late Deadline November 1st):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

This webinar will review the results of the ISCT COGs Survey circulated to Membership in June, 2013. The COGs Survey explored a range of considerations for cell therapy manufacturing (both autologous and allogeneic) as it relates to managing COGs (cost of goods). The goal of the survey was to gain better knowledge of current practices and experience in cell therapy manufacturing development. Understanding where cell therapy manufacturing standards are today, will help guide the drafting of a COGs white paper to provide a road map of considerations and resources for manufacturing / COGs planning and decision making. This is a key strategic discipline for developing cell therapies with the goal of optimal pricing, for broad adoption and reimbursement, leading to successful commercialization.

Join members of the ISCT Business Models and COGs subcommittee as they review the results and key learning gained from the responses. The committee will identify areas of focus for cost of goods considerations and introduce future plans for addressing the needs identified.


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Preparing the Lab for a New Clinical Trial

Organized by the ISCT Lab Practices Committee

November 6th, 2013
12pm ET to 1:00pm ET

Chair: Joseph Mierski, MSc, Hematopoietic Cell Therapy Lab Coordinator,
Penn State Hershey Medical Center

Speaker(s): Todd Schuesler, Supervisor, Hoxworth Cellular Therapy Department, Chris Bruns, Clinical Manufacturing Manager, Athersys, Inc.

Registration (Early Deadline October 30th, Late Deadline November 4th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

In recent years the number of cellular based clinical trials has increased dramatically. As these types of studies continue to be developed there will be a need for cellular therapy laboratories to acquire the administrative, technical, and regulatory knowledge to be successful. The presenters of this webinar will discuss the necessary steps involved in preparing your laboratory for supporting both internally and externally sponsored clinical trials. The presentation includes speakers providing insight from both the cell therapy laboratory and industry perspectives.

Objectives:

  • Experiences and lessons learned from the preparation of a CT Lab for an internally sponsored clinical trial.
  • What to expect when participating in a clinical trial with an external sponsor.
  • Quality Assurance and Regulatory considerations from both internally and externally sponsored clinical trials.

 

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CliniMACS Prodigy - Mastering the Complexity of Cell Processing

Complimentary Webinar Sponsored by Miltenyi Biotec

November 13th, 2013
12pm ET to 1:00pm ET

Chair:Hermann R. Bohnenkamp, Ph.D., Miltenyi Biotec GmbH, Bergisch Gladbach, Germany

Speakers:Laurence J.N. Cooper, M.D., Ph.D., MD Anderson Cancer Center, Houston, Texas, USA and Mario Assenmacher, Ph.D., Miltenyi Biotec GmbH, Bergisch Gladbach, Germany

Registration Deadline: November 11th

No Fees to Register

About the Webinar:

Since its introduction in 1997, the CliniMACS Cell Separation System has become a proven technology for the development and establishment of cell-based therapies. Now, the new CliniMACS Prodigy System provides advanced integrated solutions for streamlining cell-processing workflows: from cell separation, through cell culture, to formulation of the final product. With this flexible technology platform, fully automated cell processing for innovative and complex cell manufacturing protocols becomes a reality.

Within this webinar the CliniMACS Prodigy System will be introduced and the Cytokine Capture System (IFN-gamma) process for the manufacturing of multi-antigen specific T cells will be outlined.

Adoptive transfer of T-lymphocytes with specificities for one or several viruses is a promising strategy to treat or prevent opportunistic infections in immunocompromised individuals, e.g. in patients after allogeneic hematopoietic stem cell transplantation. In this webinar the rapid and fully automated generation of virus-specific T-cells reactive against CMV, AdV, and EBV antigens will be described.

Additionally, the comparison of the cellular products generated by the established CliniMACS plus procedure with the CliniMACS Prodigy System will be discussed. Tri-virus-specific T-cells and its composition in respect to single antigen specificities will be phenotypically and functionally analyzed.

Learning objectives:

  • Manufacturing processes for complex procedures
    • Introduction to the CliniMACS Prodigy Instrument
  • Technical challenges for manufacturing multi-antigen specific T cells for clinical use
    • Manufacturing of single- or multi-antigen specific T cells
    • Verification and comparability of CliniMACS plus and CliniMACS Prodigy Instruments
  • Analysis of the cellular product
    • Phenotypical and functional analysis platform for antigen-specific T cells

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Towards Bioengineered Control of Cell Fate Post Transplantation

Organized by the ISCT Commercialization Committee

November 20th, 2013
12pm ET to 1:00pm ET

Chair: Aleksander Francki, PhD, Senior Principal Scientist, Celgene Cellular Therapeutics, USA

Speaker: Jeffrey M. Karp, PhD, Associate Professor of Medicine, Brigham and Women's Hospital, Harvard Medical School, USA

Registration (Early Deadline November 13th, Late Deadline November 18th):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

Control of cell fate and its extracellular environment is critical for tissue regeneration and cell therapy. This talk will explore methods to enhance the engraftment of systemically infused stem cells through engineering the cell surface to induce a robust rolling response. This approach is based on leukocytes ability to target tissues via specific interactions with the vascular endothelium. In addition, a strategy to engineer cells with an intracellular depot of phenotype altering agents will be described that can be used for drug delivery or programming cell fate via both intracrine-, paracrine-, and endocrine-like mechanisms. The talk will also examine the potential of cell surface sensors that can be used to detect signals within the cellular nano-environment with unprecedented spatial and temporal resolution. This should be useful for monitoring the cell secretome following transplantation, for drug discovery and for elucidating niche biology in vivo.

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Technological Advances in Contamination Testing

Organized by the ISCT NA Legal and Regulatory Affairs Committee

November 25th, 2013
12pm ET to 1:00pm ET

Chair: Olive Sturtevant, MHP, MT(ASCP)SBB,SLS, CQA(ASQ), Director, Cell Therapy Quality Assurance, Dana Farber Cancer Institute, Massachusetts, USA

Speakers:Enrique Alvarez, BS, MLS (ASCP)CM, CQA (ASQ), Assistant Director Cell Therapy Laboratory, Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center and Russell C. Marians, PhD, Manager, Molecular and Cell Biology, LABS, Inc.

Registration (Early November 18th, Late Deadline November 21st):

Early registration for members: $90, non-members: $105
Late registration for members: $105, non-members: $120

About the Webinar:

This presentation will review the recent technological advances to microbial detection systems that are available for use on products frequently encountered in a Cellular Therapy laboratory. Not all methods are appropriate for all cellular products, as product matrix may impact detection ability of the testing systems. When selecting testing platforms, one must evaluate the sensitivity, specificity and limitations for each method against the intended use and verify the acceptability for each unique product formulation. Speakers in this session will review the current available methods for Sterility, Endotoxin and Mycoplasma assessment.

Sterility and Endotoxin Testing for Cellular Products

Learning Objectives:

  1. Review, compare and contrast the current methods available in the market place for sterility and endotoxin testing.
  2. Discuss which method may be appropriate for specific cell therapy products and the challenges we face based on timing of the testing and formulation of final product.
  3. Discuss an overview of validation / verification methods for the various testing platforms.

PCR-Based Mycoplasma Testing for Live Cell Products

Learning Objectives:

  1. Gain insight into which test performance parameters are important in selecting a PCR-based Mycoplasma test
  2. Gain appreciation that rapid Mycoplasma detection methods have not been universally approved for use in the industry
  3. Learn to differentiate circumstances where a validated PCR detection method is sufficient vs. when it is necessary to compare performance of a PCR-based test to the standard culture-based methodologies

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[reference page]

[original webinar page includes webinar landing page, 2013 webinar schedule, and past webinars which go through 2008... lots of migration...]