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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 381-390 of 698 items.
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Understanding 21 CFR Part 11 Validation - Procedures for Controlling Electronic Signatures and Elect...
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...
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ICH Q10- Establishing The Pharmaceutical Quality System
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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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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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CRO Oversight: Practicalities, Roles and Responsibilities Discussion
Dr. Laura Brown
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | 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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How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
Dr. Loren Gelber
Recorded Duration : 90 Minutes
Life Sciences > Pharma | Biotech | Medical Devices
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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How to Implement the ISO 13485 in Your Company?
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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Sustainable Vendor Qualification in Pharma Industry
Gowri Sukumar
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the te...

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Clinical QMS Compliance
Dr. Laura Brown
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | 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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3-hr Virtual Seminar: Understanding GMP & cGMP Compliance - What it really means
Lynette N. Pious
Recorded Duration : 180 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Lynette N. Pious is a quality systems and regulatory affairs consultant in the cosmetic, personal care and pharmaceutical industries. Lynette is the President and CEO of Pious...
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The Requirements and Responsibilities of a HIPAA Security | Privacy Officer
Howard Jones
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Howard Jones is keynote speaker at Compliance Key, Inc. He has been an independent consultant to physicians and hospitals since 1980. He has pr...

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