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Essentials of Validation – IQ, OQ, PQ
LIVE : April 08 , 2025 01:00 PM EST
Life Sciences > Medical Devices
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21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration
Jose Mora
LIVE : April 09 , 2025 01:00 PM EST
Life Sciences > Medical Devices
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences ind...
Showing 241-250 of 703 items.
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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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The Most Common Problems in FDA Software Validation & Verification
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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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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