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The Most Common Problems in FDA Software Validation & Verification
John E. Lincoln
LIVE : July 09 , 2025 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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...

Showing 401-410 of 705 items.
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Top Process Validation Mistakes - And How to Avoid Them
Susanne Manz
Recorded Duration : 60 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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Reporting HIPAA Breaches: Protection and Prevention
Pam Joslin, MM, CMC, CMIS, CMOM, CMCO, CEMA, CMCA-E/M
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Pam has more than 20 years of medical practice management, billing and coding, reimbursement, auditing and compliance experience.

S...

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Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
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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Validating Preventive Controls: Prepare to Meet the FDA FSMA Preventive Controls for Human and Anima...
John Ryan
Recorded Duration : 60 Minutes
Life Sciences > Food Safety And Dietary Supplements

Dr. John Ryan is the president of RyanSystems.com and holds a Ph.D. in research and statistical methods.  For more than 25 years, he has i...

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Technology Transfer for Pharmaceutical Processes and Test Methods
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...
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ICD 10 - CM Z Code Guidelines - Cracking the Z Codes: Discovering Hidden Treasures with Value-Based ...
Pam Joslin, MM, CMC, CMIS, CMOM, CMCO, CEMA, CMCA-E/M
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Pam has more than 20 years of medical practice management, billing and coding, reimbursement, auditing and compliance experience.

S...

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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
Dr. Loren Gelber
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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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CAPA Simplified – A one-form, Easy-to-Complete, Method for Simplifying Your CAPA Process
Denise Wrestler, ASQ CQE, CQA
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With over 15 years of experience

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3-hr Virtual Seminar: Validation and Part 11 Compliance of Computer Systems
Joy L. McElroy
Recorded Duration : 180 Minutes
Life Sciences > 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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Good Manufacturing Practices for Phase 1 Investigational Drug Products
Stephanie Cooke
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical

Stephanie Cooke is the President & CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in...

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