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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 291-300 of 702 items.
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Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities
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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FDA Case Scenarios – Best Practices for Managing Inspection Situations
Danielle DeLucy
Recorded Duration : 75 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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Attaining Your CE Mark for Your Medical Device in the EU
Charles H. Paul
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Developing a HIPAA Compliant Disaster Recovery Plan - Are You Prepared?
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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4-hr Virtual Seminar: Design Control Program with Detailed Hazard Analysis, Human Factors and Softwa...
Edwin Waldbusser
Recorded Duration : 240 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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21 CFR Part 11 (electronic records/signatures) Compliance 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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Understanding and Preventing Cleanroom Contamination: Gaining and Re- establishing Control of your C...
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical

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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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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