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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 471-480 of 702 items.
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Human Factors Engineering in New Product Development
Tom Kramer
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26

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Cleanroom Practices and General Chapter USP <797>
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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Cleanroom Practices and General Chapter USP <797>
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotchnology | 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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Medical Device Classification Process in the United States and the EU
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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How to Prepare HIPAA Compliant Policies and Procedures
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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Demonstrated Techniques to a Successful 510k Submission
Mercedes Massana
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, bio...
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HIPAA vs SAMHSA (42 CFR Part 2)
Brian Tuttle
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
Brian Tuttle CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor ...
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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 Devices

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

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Cosmetic Testing for US FDA Compliance
Rachelle D'Souza
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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Vendor Auditing of an FDA-Regulated Computer System
Carolyn Troiano
Recorded Duration : 90 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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