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

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
- Speaker: Karl M. Nobert
- Product ID: 701927
- Duration: 90 Min
CD/Recorded
$399
$399
Recorded/CD

Automating Assays for Clinical Diagnostics
- Speaker: Todd Graham
- Product ID: 703268
- Duration: 60 Min
Recorded/CD

Validation of Complex Cell-Based Potency Methods
- Speaker: Gwen Wise Blackman
- Product ID: 705172
- Duration: 60 Min
CD/Recorded
$249
$249
Recorded/CD

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
- Speaker: Henry Urbach
- Product ID: 703474
- Duration: 90 Min
CD/Recorded
$249
$249
Recorded/CD

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production
- Speaker: Henry Urbach
- Product ID: 705072
- Duration: 90 Min
CD/Recorded
$249
$249
Recorded/CD

Steam Sterilization Microbiology and Autoclave Performance Qualification
- Speaker: Aaron Mertens
- Product ID: 704850
- Duration: 90 Min
Recorded/CD

Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics
- Speaker: Rajesh Gupta
- Product ID: 704755
- Duration: 60 Min
Recorded/CD

FDA Guidelines on Usage of Stem Cells in Medicines
- Speaker: Thomas Webster
- Product ID: 704495
- Duration: 120 Min
Recorded/CD

Documentation Requirements for Master and Working Cell Banks
- Speaker: Debra Barngrover
- Product ID: 704030
- Duration: 60 Min
CD/Recorded
$229
$229
Recorded/CD

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
- Speaker: Mukesh Kumar
- Product ID: 703652
- Duration: 90 Min
CD/Recorded
$229
$229
Recorded/CD

FDA Regulation of Therapeutic Use of Live Cells
- Speaker: Igor Zlatkin
- Product ID: 703463
- Duration: 60 Min
CD/Recorded
$229
$229
Recorded/CD

How To Translate Academic and Discovery Assays Into GLP Compliant Assays
- Speaker: Todd Graham
- Product ID: 703275
- Duration: 60 Min
CD/Recorded
$229
$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
- Speaker: Karl M. Nobert
- Product ID: 702322
- Duration: 60 Min
CD/Recorded
$229
$229
Recorded/CD

Recommendations for Cell Banks used in GXP testing
- Speaker: Ana Menendez
- Product ID: 702327
- Duration: 60 Min
CD/Recorded
$229
$229
Recorded/CD

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
CD/Recorded
$799
$799
Recorded/CD

Cell Culture Media Filtration - Points to Consider
- Speaker: Maik Jornitz
- Product ID: 701366
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

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
CD/Recorded
$249
$249
Recorded/CD

Implementing Process Controls for Optimum Performance of Cell-Based Assays
- Speaker: Dr. Wise Blackman
- Product ID: 700191
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Current Regulatory Requirements for Sterile Products
- Speaker: Kenneth Christie
- Product ID: 703672
- Duration:
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