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Essentials of Validation – IQ, OQ, PQ
LIVE : April 08 , 2025 01:00 PM EST
Life Sciences > Medical Devices
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21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration
Jose Mora
LIVE : April 09 , 2025 01:00 PM EST
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...
Showing 231-240 of 703 items.
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Process Validation Requirements and Compliance strategies
Jose Mora
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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HIPAA Privacy Exceptions And The Duty To Warn Under State Law
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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Measuring and Understanding Cognitive Overload and Human Error
Dr. Ginette Collazo
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...
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Medical Device Cybersecurity Following Latest FDA Guidance
Edwin Waldbusser
Recorded Duration : 60 Minutes
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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FDA Aseptic Processing Guidance Document
Carl Patterson, MS, SSGB, SSBB
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, Ca...

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Data Governance for Computer Systems Regulated by FDA
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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Effective Batch Record Reviews to Improve your Process Capabilities
Danielle DeLucy
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Understanding and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled i...
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How to Deal with Medical Device Tracking Requirements
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations
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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