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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 391-400 of 698 items.
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Successfully Dealing with Out of Specification (OOS) Test results in the Pharmaceutical and Medical ...
Meena Chettiar
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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Medical Device Single Audit Program (MDSAP) - A New Face of Audit
Parul Chansoria, RAC
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Parul is a Medical Device Professional with successful experience in initiation & implementation of Quality & Regulatory activities for different phases of a medical p...
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Compliance with the New ICH GCP Revision 2 Addendum
Dr. Laura Brown
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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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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