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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 ...
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The DOJ Gets Personal: 6 Things You Should Know About the Yates Memo
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
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Ensuring Compliance Of Your Bioanalytical Method Validation With The 2013 FDA Draft Guidance
Brian Kirk
Recorded Duration : 75 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
Brian A. Kirk, Ph.D. has been employed in both the biotech and pharmaceutical industries for over 20 years. He has a wealth of experience, working in the areas of synthetic or...
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Food Importation and FDA Oversight
Joe Lynch
Recorded Duration : 75 Minutes
Life Sciences > Food Safety And Dietary Supplements

Joe Lynch is the founder of The Logistics of Logistics, a logistics training and consulting firm. Joe specializes in helping logistics and tran...

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Good Laboratory Practices (GLPS) Comparing and Contrasting With Good Manufacturing Practices (GMPS)
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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Validation Of Preventive Controls-Prepare Your Company to Meet The Final FSMA Rule Requirements for ...
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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The Importance of Protocol Deviations and Violations to Subject Safety and Data Integrity will Surpr...
Dr. Charles H Pierce
Recorded Duration : 90 Minutes
Life Sciences > Clinical Trial

Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) throug...

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Validation Of Pharmaceutical Compressed Gasses
Igor Gorsky
Recorded Duration : 75 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Igor Gorsky, Sr. Consultant, ConcordiaValsource, LLC. He has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions...
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Reprocessing Reusable Medical Devices Cleaning & Labeling Requirements
John Chapman
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC....
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How to Get That 510(K) Out Of The Way
Jim Dunning
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jim’s consulting career began in 2001 and has consulted in quality and regulatory for companies ranging from Fortune 500 medical device companies to start-up medical device ...
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Transitioning Assays From Different Technologies: Validation and Qualification
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Biotechnology
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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