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Showing 1-8 of 8 items.
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Risk Assessment in Medical Device Design
Charles H. Paul
LIVE : January 08 , 2025 01:00 PM EST
Life Sciences > Medical Devices
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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The DHF, DMR, DHR, and Technical Documents File
John E. Lincoln
LIVE : January 09 , 2025 01:00 PM EST
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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Training for New Technical Writers
Robert Peoples
LIVE : January 13 , 2025 01:00 PM EST
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemi...

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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Jose Mora
LIVE : January 16 , 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...
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Write it Right – Well Written Procedures are Essential for QMS Effectiveness
Joy L. McElroy
LIVE : January 17 , 2025 01:00 PM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...
Joy L. McElroy
LIVE : January 22 , 2025 01:00 PM EST
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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FDA Audit Best Practices - Dos and Don'ts
Charles H. Paul
LIVE : January 24 , 2025 01:00 PM EST
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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Validation of Complex Cell-Based Potency Methods
Gwendolyn Wise-Blackman
LIVE : January 31 , 2025 01:00 PM EST
Life Sciences > Clinical Trial
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 ...
Showing 471-480 of 697 items.
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Demonstrated Techniques to a Successful 510k Submission
Mercedes Massana
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, bio...
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HIPAA vs SAMHSA (42 CFR Part 2)
Brian Tuttle
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
Brian Tuttle CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor ...
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Documentation Successful 510 (k) Documentation for Software or Software Containing Medical Devices
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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Cosmetic Testing for US FDA Compliance
Rachelle D'Souza
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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Vendor Auditing of an FDA-Regulated Computer System
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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Building Your Company FDA FSMA Preventive Control and Food Defense Plans
John Ryan
Recorded Duration : 75 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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Review Process of Advertising and Promotional Material Compliance
Peggy J Berry
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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Applying Global Standards to Life Sciences Compliance Documentation
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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The FDA Inspection: Preparation, Performance and Follow-Up
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
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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Three Ways Home Healthcare is Changing the Medical Device Game
Tom Kramer
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26

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