WEBINARS

 

Cellular and Gene Therapy 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

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

Validation of Complex Cell-Based Potency Methods

webinar-speaker   Gwen Wise Blackman

webinar-time   60 Min

Product Id: 705172

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.

Recording Available

* Per Attendee $249

 

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

 

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

 

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

webinar-speaker   Rajesh Gupta

webinar-time   60 Min

Product Id: 704755

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.

Recording Available

 

FDA Guidelines on Usage of Stem Cells in Medicines

webinar-speaker   Thomas Webster

webinar-time   120 Min

Product Id: 704495

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.

Recording Available

 

Documentation Requirements for Master and Working Cell Banks

webinar-speaker   Debra Barngrover

webinar-time   60 Min

Product Id: 704030

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.

Recording Available

* Per Attendee $229

 

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 Regulation of Therapeutic Use of Live Cells

webinar-speaker   Igor Zlatkin

webinar-time   60 Min

Product Id: 703463

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.

Recording Available

* Per Attendee $229

 

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703275

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.

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

 

Recommendations for Cell Banks used in GXP testing

webinar-speaker   Ana Menendez

webinar-time   60 Min

Product Id: 702327

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.

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

 

Cell Culture Media Filtration - Points to Consider

webinar-speaker   Maik Jornitz

webinar-time   60 Min

Product Id: 701366

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Dr. Wise Blackman

webinar-time   90 Min

Product Id: 701059

This webinar will provide guidance in developing assays that will meet specifications thus reducing OOS and OOT results.

Recording Available

* Per Attendee $249

 

Implementing Process Controls for Optimum Performance of Cell-Based Assays

webinar-speaker   Dr. Wise Blackman

webinar-time   60 Min

Product Id: 700191

Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts.

Recording Available

* Per Attendee $299

 

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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