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Showing 1-7 of 7 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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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 401-410 of 698 items.
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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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The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under on...
Meena Chettiar
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University ...

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Artificial Intelligence (IA) in the Food Supply Chain Current and Future Potential
Dr. John Ryan
Recorded Duration : 60 Minutes
Life Sciences > Food Safety And Dietary Supplements

Dr. John Ryan is a certified Preventive Controls Qualified Individual (PQCI) specializing in food safety process control and food safety plan v...

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Non-conforming Material and Failure Investigation
Susanne Manz
Recorded Duration : 90 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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Business Process Re-engineering and FDA-Regulated Computer System Projects
Carolyn Troiano
Recorded Duration : 60 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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Guidance on Quality Agreements for FDA Regulated Industries
Joy L. McElroy
Recorded Duration : 75 Minutes
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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Preparing for FDA Audits and Responding to FDA 483s in Pharmaceutical and Medical Device Industries
Meena Chettiar
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University ...

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2-hr Virtual Seminar: Advance Preparation and Planning for Notified Bodies Unannounced Audits
Vanessa Lopez
Recorded Duration : 120 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Vanessa Lopez is senior principle quality,  regulatory and compliance consultant. She has held a wide variety of leadership roles in the m...

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