ComplianceOnline

Cellular and Gene Therapy Regulatory Compliance Training - Live Webinars, Recordings & CDs

Recorded/CD
Validation of Complex Cell-Based Potency Methods

Validation of Complex Cell-Based Potency Methods

  • Speaker: Gwen Wise Blackman
  • Product ID: 705172
  • Duration: 60 Min
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
CD/Recorded
$249
Recorded/CD
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 703474
  • Duration: 90 Min
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.
CD/Recorded
$249
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
CD/Recorded
$249
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Aaron Mertens
  • Product ID: 704850
  • Duration: 90 Min
This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.
Recorded/CD
Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

  • Speaker: Rajesh Gupta
  • Product ID: 704755
  • Duration: 60 Min
This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.
Recorded/CD
FDA Guidelines on Usage of Stem Cells in Medicines

FDA Guidelines on Usage of Stem Cells in Medicines

  • Speaker: Thomas Webster
  • Product ID: 704495
  • Duration: 120 Min
This training program will discuss stem cell sources and how to control stem cell differentiation, technologies (FDA and non-FDA) that exist in stem cell technologies, and the future directions and opportunities that exist for stem cell technologies.
Recorded/CD
Documentation Requirements for Master and Working Cell Banks

Documentation Requirements for Master and Working Cell Banks

  • Speaker: Debra Barngrover
  • Product ID: 704030
  • Duration: 60 Min
This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.
CD/Recorded
$229
Recorded/CD
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
CD/Recorded
$229
Recorded/CD
FDA Regulation of Therapeutic Use of Live Cells

FDA Regulation of Therapeutic Use of Live Cells

  • Speaker: Igor Zlatkin
  • Product ID: 703463
  • Duration: 60 Min
This webinar will discuss the FDA rules and regulations regarding the potential of using live cells in medicine. It will cover FDA guidance documents for cellular and gene therapy and major differences between the rules in the USA and other countries.
CD/Recorded
$229
Recorded/CD
How To Translate Academic and Discovery Assays Into GLP Compliant Assays

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

  • Speaker: Todd Graham
  • Product ID: 703275
  • Duration: 60 Min
This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.
CD/Recorded
$229
Recorded/CD
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

  • Speaker: Karl M. Nobert
  • Product ID: 701927
  • Duration: 90 Min
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
CD/Recorded
$229
Recorded/CD
FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals

FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals

  • Speaker: Karl M. Nobert
  • Product ID: 702322
  • Duration: 60 Min
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
CD/Recorded
$229
Recorded/CD
Recommendations for Cell Banks used in GXP testing

Recommendations for Cell Banks used in GXP testing

  • Speaker: Ana Menendez
  • Product ID: 702327
  • Duration: 60 Min
This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability.
CD/Recorded
$229
Recorded/CD
3-hr Virtual Seminar - Regenerative Medicine: An Introduction to FDA's Regulation of Cell Therapies and HCT/Ps Generally

3-hr Virtual Seminar - Regenerative Medicine: An Introduction to FDA's Regulation of Cell Therapies and HCT/Ps Generally

  • Speaker: Karl M. Nobert
  • Product ID: 702155
  • Duration: 3 hrs
This 3-hr virtual seminar will cover the USFDA's regulation of cell therapies and HCT/Ps, FDA's labeling and promotional rules and the agency's current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.
CD/Recorded
$799
Recorded/CD
Cell Culture Media Filtration - Points to Consider

Cell Culture Media Filtration - Points to Consider

  • Speaker: Maik Jornitz
  • Product ID: 701366
  • Duration: 60 Min
This Cell Culture Media training will review the different performance parameters and describe challenge test results which have been found in a comparison study of multiple 0.1 micron rated filters.
CD/Recorded
$299
Recorded/CD
Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a Successful Transfer

Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a Successful Transfer

  • Speaker: Dr. Wise Blackman
  • Product ID: 701059
  • Duration: 90 Min
This webinar will provide guidance in developing assays that will meet specifications thus reducing OOS and OOT results.
CD/Recorded
$249
Recorded/CD
Implementing Process Controls for Optimum Performance of Cell-Based Assays

Implementing Process Controls for Optimum Performance of Cell-Based Assays

  • Speaker: Dr. Wise Blackman
  • Product ID: 700191
  • Duration: 60 Min
Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts.
CD/Recorded
$299
Recorded/CD
Current Regulatory Requirements for Sterile Products

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration:
This course will focus on current validation requirements for the manufacture of sterile products and the key areas of importance and audit focus. The instructor will suggest several industry best practices and review a checklist of process and procedures to ensure compliance to current requirements.
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