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Showing 1-8 of 8 items.
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How to Write SOP’s for Human Error Reduction
Dr. Ginette Collazo
LIVE : November 01 , 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 the Five Pillars of 5S for Operators
LIVE : November 04 , 2024 01:00 PM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
LIVE : November 06 , 2024 01:00 PM EST
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

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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Write it Right – Well Written Procedures are Essential for QMS Effectiveness
Joy L. McElroy
LIVE : November 07 , 2024 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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Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions
Joy L. McElroy
LIVE : November 14 , 2024 01:00 PM EST
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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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : November 19 , 2024 11:00 AM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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4-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst...
Joy L. McElroy
LIVE : November 21 , 2024 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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Technical Writing Best Practices
Robert Peoples
LIVE : November 21 , 2024 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...

Showing 231-240 of 696 items.
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Understanding and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled i...
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How to Deal with Medical Device Tracking Requirements
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations
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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Understanding Sponsor's Responsibilities for an Active IND
Gowri Sukumar
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | 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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E/M Auditing Fundamentals
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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HIPAA Privacy and Public Health Exceptions
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare | Clinical | Pharmaceuticals
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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Data Integrity for medical device development companies & Part 11 under the FDA QSR
Don Hurd
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, in...

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6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Carolyn Troiano
Recorded Duration : 360 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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Navigating the IND - Guide to Assemble an Acceptable IND Dossier.
Barry Rosenblatt, PhD
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Dr. Rosenblatt is a subject matter expert in the chemistry and manufactur...
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Developing a Validation Master Plan
Marie Dorat
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years  experience, in the Pharmaceutical/Medical Device...
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