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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 ...
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : October 22 , 2025 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Essentials of Validation – IQ, OQ, PQ
LIVE : October 23 , 2025 01:00 PM EDT
Life Sciences > Medical Devices
Showing 361-370 of 702 items.
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Documentation Successful 510 (k) Documentation for Software or Software Containing Medical Devices
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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How to Ensure a Successful Health Care Systems Implementation
Jim Wener
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Jim Wener has over 40 years of experience in assisting health care organizations - both providers and payers - in identifying their automation ...

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Essential Regulatory Documentation in Clinical Research with Medical Devices
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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Update on the Joint Commission 2019 Focus areas: The Need for Mindfulness
Dr. Marge McFarlane, PhD, MT (ASCP), CHFM, CJCP, CHSP, HEM, MEP
Recorded Duration : 60 Minutes
Life Sciences > Healthcare | Clinical | Laboratory

Marge McFarlane, PhD, MT (ASCP), CHFM, CJCP, CHSP, HEM, MEP, brings over 40 years of comprehensive experience in the environment of care, life ...

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Managing Phase I Clinical Trials
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Healthcare | Clinical | Laboratory

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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How to Respond to a HIPAA Breach
Jim Wener
Recorded Duration : 60 Minutes
Life Sciences > Healthcare | Clinical | Laboratory

Jim Wener has over 40 years of experience in assisting health care organizations - both providers and payers - in identifying their automation ...

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Cannabinoids As Drugs – Latest Updates
Dr. Loren Gelber
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC d...
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Trial Master File: Designing, Operationalizing and Maintaining a Comprehensive Assessment
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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Understanding the Role of IT in HIPAA Compliance
Jim Wener
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Jim Wener has over 40 years of experience in assisting health care organizations - both providers and payers - in identifying their automation ...

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Handling Protocol Deviations and Violations to Be GCP and Regulatory Compliant
Dr. Charles H Pierce
Recorded Duration : 90 Minutes
Life Sciences > Healthcare | Clinical | Pharmaceuticals

Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) throug...

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