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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA
CAROLYN TROIANO
LIVE : September 28 , 2023 01:00 PM EDT
Life Sciences > Medical Devices
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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Sample Size Determination for Design Validation Activities
STEVEN WACHS
LIVE : September 29 , 2023 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has...
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : October 02 , 2023 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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How FDA trains its Investigators to Review CAPA and How should you prepare
CHARLES H. PAUL
LIVE : October 02 , 2023 03:00 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 Complaint Systems, FDA's Adverse Event Reporting & Product Recalls
JOY L. MCELROY
LIVE : October 03 , 2023 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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Healthcare Compliance Program: Auditing and Monitoring
MARINA MALIKOVA
LIVE : October 03 , 2023 03:00 PM EDT
Life Sciences > Healthcare

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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Effective Pharmaceutical GMP Audits and Self-Inspections
CARL PATTERSON, MS, SSGB, SSBB
LIVE : October 05 , 2023 03:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, Ca...

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HIPAA Rules for Social Media, Web Sites & Patient Reviews
PAUL HALES
LIVE : October 05 , 2023 01:00 PM EDT
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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How to Prepare a Standard Operating Procedure
DR. AFSANEH MOTAMED KHORASANI
LIVE : October 06 , 2023 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Sunshine Act Reporting – Clarification for Clinical Research
DANIELLE DELUCY
LIVE : October 10 , 2023 01:00 PM EDT
Life Sciences > Clinical | Biotechnology | 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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Best Practices in Preparation for FDA Computer System Validation Audit
CAROLYN TROIANO
LIVE : October 11 , 2023 01:00 PM 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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Performing Effective and Compliant Sterility Failure Investigations
JOY L. MCELROY
LIVE : October 18 , 2023 01:00 PM EDT
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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Risk Assessment in Medical Device Design
CHARLES H. PAUL
LIVE : October 19 , 2023 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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Trial Master File (TMF): Meeting FDA Expectations
CAROLYN TROIANO
LIVE : October 25 , 2023 01:00 PM EDT
Life Sciences > Clinical Trial
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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Medical Device Non-Product Software Validation Training
JOHN E. LINCOLN
LIVE : October 25 , 2023 01:00 PM EDT
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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Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
CHARLES H. PAUL
LIVE : October 27 , 2023 03:00 PM EDT
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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