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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 ...
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The Human Error Tool Box: A Practical Approach to Human Error
Dr. Ginette Collazo
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
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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Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in your Company Required by the...
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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CGMP: Pharmaceutical CAPAs (GMP10)
Kelly Thomas
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her ex...

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3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
Carolyn Troiano
Recorded Duration : 180 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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COVID-19: Recovering from COVID--The Next Step for Hospital Case Managers and Case Management Leade...
Beverly Cunningham
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Bev Cunningham, MS, RN, ACM is a founding partner of Case Management Concepts, LLC. She has a 25-year deep working knowledge of case management...

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The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory
John C. Fetzer
Recorded Duration : 60 Minutes
Life Sciences > Laboratory
John C. Fetzer, has had over 30 year experience in GC and GC-MS methods development. He has authored or co-authored over 50 peer-reviewed papers on chromatography, has served ...
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Aseptic Processing Overview and Validation
Kelly Thomas
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her ex...

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Effective FDA Complaint Handling and Product Recalls
Joy L. McElroy
Recorded Duration : 75 Minutes
Life Sciences > Pharma | Biotech | Medical Devices

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 Risk Management Following ISO 14971:2019
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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