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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
LIVE : April 22 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical sc...

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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy L. McElroy
LIVE : April 23 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | 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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Impact Assessments and Risk Management for Change Control
Alan Golden
LIVE : April 24 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Ab...

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3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...
Joy L. McElroy
LIVE : April 25 , 2024 01:00 PM EDT
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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Human Factors-Usability Based on ISO 62366
John E. Lincoln
LIVE : April 26 , 2024 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...

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Understanding the Five Pillars of 5S for Operators
Dr. Ginette Collazo
LIVE : April 29 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...
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Understanding Combination Products: Navigating the Rules and Regulations
Charles H. Paul
LIVE : April 30 , 2024 01:00 PM EDT
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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GMP Auditing of Facilities Performing Cell-Based Methods
Gwendolyn Wise-Blackman
LIVE : May 31 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
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 91-100 of 685 items.
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The GCPs: How to Implement for Compliant Clinical Trials
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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HHS Mandatory Email & Text Message Encryption Rules with Only One Exception for Informed Patients
Paul Hales
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
Paul R. Hales, J.D. is widely recognized for his ability to explain HIPAA Rules clearly in plain language. He is an attorney licensed to practice before the Supreme Court of t...
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Validation Challenges for Bioassays
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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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Good Documentation Practices
Danielle DeLucy
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...
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IQ, OQ, PQ in the Verification and Validation Process
John E. Lincoln
Recorded Duration : 90 Minutes
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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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
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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Medical Devices – US & International Regulatory Compliance and Regulatory Affairs
Charles H. Paul
Recorded Duration : 60 Minutes
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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2023 New HIPAA Business Associate Enforcement – CE & BA Takeaways
Paul Hales
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Paul R. Hales, J.D. is widely recognized for his ability to explain HIPAA Rules clearly in plain language. He is an attorney licensed to practice before the Supreme Court of t...
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4 Hours Virtual Seminar: Risk Management in the Medical Device Design Process
Charles H. Paul
Recorded Duration : 240 Minutes
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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Documenting a Risk-Based Quality System for Compliance and Cost-Savings
John E. Lincoln
Recorded Duration : 90 Minutes
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...

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