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Showing 11-18 of 18 items.
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Clinical Process Improvement
Joy L. McElroy
LIVE : June 03 , 2024 01:00 PM EDT
Life Sciences > Clinical | Biotechnology | 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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Essentials of Validation – IQ, OQ, PQ
LIVE : June 04 , 2024 01:00 PM EST
Life Sciences > Medical Devices
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4 Hour Virtual Seminar on Batch Record Review and Product Release
Danielle DeLucy
LIVE : June 05 , 2024 01:00 PM EDT
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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6-hr Virtual Seminar: Quality Control Laboratory Compliance - cGMPs and GLPs
Joy L. McElroy
LIVE : June 06 , 2024 11:00 AM EDT
Life Sciences > 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?
Susanne Manz
LIVE : June 18 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
LIVE : June 19 , 2024 11:00 AM EDT
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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6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance...
LIVE : June 25 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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4-Hour Virtual Training: How to Respond to an FDA Investigation
Joy L. McElroy
LIVE : June 26 , 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. ...

Showing 131-140 of 677 items.
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Best Practices and Common Pitfalls Related to FDA Compliance for Computer System Validation (CSV)
Carolyn Troiano
Recorded Duration : 90 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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U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
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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Introduction to FDA and EU Medical Device Submissions
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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3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures ...
Carolyn Troiano
Recorded Duration : 180 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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Technical Writing for a Traditional 510(k) Submission
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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The End of the Public Health Emergency is Near: What Your Health Care Organization Needs to do Now?
Joseph Wolfe
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Joseph Wolfe is an attorney with Hall Render, the largest healthcare-focused law firm in the country. Mr. Wolfe supports high-performing hospitals, health systems, medical gro...
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3-hr Virtual Seminar on IEC 62304 and Demystifying Software Validation
Jose Mora
Recorded Duration : 180 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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How to Prepare a 510(k) Submission
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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3-Hour Virtual Seminar: Effective Cleaning Validation Procedures
Joy L. McElroy
Recorded Duration : 180 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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Regulatory Requirements for Conducting an OOS Investigation
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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