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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : March 19 , 2026 01:00 PM EST
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 141-150 of 705 items.
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Sample Size Determination for Design Validation Activities
Steven Wachs
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has...
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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
Meredith Crabtree
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Meredith Crabtree has over 25 years experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device,...

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How To Write and Manage a Change Control System
Danielle DeLucy
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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The GCPs: How to Implement for Compliant Clinical Trials
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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HHS Mandatory Email & Text Message Encryption Rules with Only One Exception for Informed Patients
Paul Hales
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
Paul R. Hales, J.D. is widely recognized for his ability to explain HIPAA Rules clearly in plain language. He is an attorney licensed to practice before the Supreme Court of t...
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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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IQ, OQ, PQ in the Verification and Validation Process
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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2023 New HIPAA Business Associate Enforcement – CE & BA Takeaways
Paul Hales
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Paul R. Hales, J.D. is widely recognized for his ability to explain HIPAA Rules clearly in plain language. He is an attorney licensed to practice before the Supreme Court of t...
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4 Hours Virtual Seminar: Risk Management in the Medical Device Design Process
Charles H. Paul
Recorded Duration : 240 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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