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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 381-390 of 702 items.
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Onboarding New or Transferred Employees in a GMP Environment
Michael Esposito
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. H...

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2-hr Virtual Seminar: Advanced Root Cause Analysis and CAPA Investigations
Susanne Manz
Recorded Duration : 120 Minutes
Life Sciences > Medical Devices
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...
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Developing HIPAA 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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Preventing Human Error in Pharmaceutical Manufacturing and Life Sciences
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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Understanding 21 CFR Part 11 Validation - Procedures for Controlling Electronic Signatures and Elect...
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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ICH Q10- Establishing The Pharmaceutical Quality System
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for ...
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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operat...
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CRO Oversight: Practicalities, Roles and Responsibilities Discussion
Dr. Laura Brown
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University...

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How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
Dr. Loren Gelber
Recorded Duration : 90 Minutes
Life Sciences > Pharma | Biotech | Medical Devices
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC d...
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How to Implement the ISO 13485 in Your Company?
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

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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