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Essentials of Validation – IQ, OQ, PQ
LIVE : April 08 , 2025 01:00 PM EST
Life Sciences > Medical Devices
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21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration
Jose Mora
LIVE : April 09 , 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...
Showing 371-380 of 703 items.
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Handling Protocol Deviations and Violations to Be GCP and Regulatory Compliant
Dr. Charles H Pierce
Recorded Duration : 90 Minutes
Life Sciences > Healthcare | Clinical | Pharmaceuticals

Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) throug...

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FDA Regulations for Analytical Instrument Qualification and Validation
Joy L. McElroy
Recorded Duration : 90 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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ICD-10-CM Official Guidelines for Coding and Reporting - FY 2019
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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Updates to the CMS Emergency Management Rules: The Journey Continues
Dr. Marge McFarlane, PhD, MT (ASCP), CHFM, CJCP, CHSP, HEM, MEP
Recorded Duration : 60 Minutes
Life Sciences > Healthcare | Clinical | Laboratory

Marge McFarlane, PhD, MT (ASCP), CHFM, CJCP, CHSP, HEM, MEP, brings over 40 years of comprehensive experience in the environment of care, life ...

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Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality
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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21 CFR Part 11 Compliance for Excel Spreadsheets
Angela Bazigos
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roc...
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Analytical Instrument Qualification and Computer System Validation
Joy L. McElroy
Recorded Duration : 90 Minutes
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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The Importance of Packaging and Labeling in Pharmaceutical Product Development
Michael Esposito
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 years experience in GMP training and document management. H...

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Software Documentation for a Successful 510k Submission
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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The Transfer of Validated Methods
John C. Fetzer
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
John C. Fetzer, has had over 30 year experience in GC and GC-MS methods development. He has authored or co-authored over 50 peer-reviewed papers on chromatography, has served ...
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