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Essentials of Validation – IQ, OQ, PQ
LIVE : October 15 , 2025 01:00 PM EDT
Life Sciences > Medical Devices
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Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
LIVE : October 16 , 2025 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical sc...

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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : October 16 , 2025 01:00 PM EDT
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 241-250 of 703 items.
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FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated ind...

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Understanding Sponsor's Responsibilities for an Active IND
Gowri Sukumar
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | 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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E/M Auditing Fundamentals
Pam Joslin, MM, CMC, CMIS, CMOM, CMCO, CEMA, CMCA-E/M
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Pam has more than 20 years of medical practice management, billing and coding, reimbursement, auditing and compliance experience.

S...

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HIPAA Privacy and Public Health Exceptions
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare | Clinical | Pharmaceuticals
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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Data Integrity for medical device development companies & Part 11 under the FDA QSR
Don Hurd
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, in...

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6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Carolyn Troiano
Recorded Duration : 360 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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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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Developing a Validation Master Plan
Marie Dorat
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years  experience, in the Pharmaceutical/Medical Device...
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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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