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Good Documentation Practices
Danielle DeLucy
LIVE : May 08 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...
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Validation of Complex Cell-Based Potency Methods
Gwendolyn Wise-Blackman
LIVE : May 09 , 2024 01:00 PM EDT
Life Sciences > Clinical Trial
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 ...
Showing 51-60 of 130 items.
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Understanding Initial IND Submission- The first 30 days
Gowri Sukumar
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the te...

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Navigating the IND - Guide to Assemble an Acceptable IND Dossier.
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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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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Microbiological Risk Analysis and HACCP
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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Packaging and Labeling in the Pharmaceutical Supply Chain
Michael Esposito
Recorded Duration : 75 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. H...

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Extractables & Leachables 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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Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out
Michael Esposito
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. H...

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