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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 101-110 of 703 items.
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Understanding Combination Products: Navigating the Rules and Regulations
Charles H. Paul
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant...
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to S...
Carolyn Troiano
Recorded Duration : 240 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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The FDA Inspection: From SOP to 483
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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PK/PD Studies in Drug Discovery and 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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Sunshine Act Reporting – Clarification for Clinical Research
Danielle DeLucy
Recorded Duration : 75 Minutes
Life Sciences > Clinical | Biotechnology | 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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Investigator Initiated Trials- What Are We Doing to Ensure Human Subject Protection?
Dr. Nagina Parmar
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Nagina Parmar has 15 years of clinical research experience as a certified clinicalresearch professional in academia and hospital. Her exper...

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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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Process Validation Requirements & Compliance Strategies
Jose Mora
Recorded Duration : 60 Minutes
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...
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Risk-based Software Verification and Validation
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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