WEBINARS

 

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

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

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 701927

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.

Recording Available

* Per Attendee $399

 

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703474

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.

Recording Available

* Per Attendee $249

 

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 705072

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 702964

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.

Recording Available

* Per Attendee $229

 

Steam Sterilization Microbiology and Autoclave Performance Qualification

webinar-speaker   Aaron Mertens

webinar-time   90 Min

Product Id: 704850

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.

Recording Available

 

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

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 703652

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Karl M. Nobert

webinar-time   60 Min

Product Id: 702322

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Karl M. Nobert

webinar-time   3 hrs

Product Id: 702155

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.

Recording Available

* Per Attendee $799

 

Important requirements when validating sterilizing grade filters

webinar-speaker   Maik Jornitz

webinar-time   55 Min

Product Id: 701110

This sterilizing grade filter validation training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes.

Recording Available

* Per Attendee $50

 

Current Regulatory Requirements for Sterile Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 703672

This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

 

 

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