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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : March 19 , 2026 01:00 PM EST
Life Sciences > Medical Devices
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...
Showing 251-260 of 705 items.
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Validation Challenges for Bioassays
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...
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Genotoxic Impurities in Drug Development
Dr. Stefano Persiani
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmac...

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Manufacturing and QC of Biopharmaceutical Drugs
Barry Rosenblatt, PhD
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Dr. Rosenblatt is a subject matter expert in the chemistry and manufactur...
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Assessment of Drug-drug Interactions in Drug Development
Dr. Stefano Persiani
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmac...

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Best Practices for Purchasing and Supplier Controls in the Medical Device Industry
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operat...
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Risk Based Approaches for Clinical Trials
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
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FDA vs Health Canada
Rachelle D'Souza
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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USP <1224> Transferring the Method to meet Regulatory Expectations
Carl Patterson, MS, SSGB, SSBB
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, Ca...

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How Will FDA’s New Approach to CSV Make Implementations Easier?
Carolyn Troiano
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...
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FDA Regulation on 3D Printing and Medical Devices
Rachelle D'Souza
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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