ComplianceOnline

Tissue and Tissue Products Regulatory Compliance Training - Live Webinars, Recordings & CDs

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
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Speaker: Henry Urbach
  • Product ID: 702964
  • Duration: 60 Min
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
CD/Recorded
$229
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
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
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
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
Important requirements when validating sterilizing grade filters

Important requirements when validating sterilizing grade filters

  • Speaker: Maik Jornitz
  • Product ID: 701110
  • Duration: 55 Min
This sterilizing grade filter validation training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes.
CD/Recorded
$25
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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