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The Most Common Problems in FDA Software Validation & Verification
John E. Lincoln
LIVE : July 09 , 2025 01:00 PM EDT
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...

Showing 361-370 of 705 items.
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Effective and Compliant Failure Investigations and writing CAPA
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. ...

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Essential Regulatory Documents and Regulatory Requirements for Biomedical Products
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | 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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Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products
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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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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