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Investigator Initiated Trials- What Are We Doing to Ensure Human Subject Protection?
DR. NAGINA PARMAR
LIVE : October 18 , 2021 01:00 PM EDT
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Nagina Parmar has 15 years of clinical research experience as a certified clinicalresearch professional in academia and hospital. Her exper...

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Verification and Validation of Production Equipment Hardware / Software
JOHN E. LINCOLN
LIVE : October 18 , 2021 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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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
ROGER COWAN
LIVE : October 19 , 2021 01:00 PM EDT
Life Sciences > Pharmaceutical
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He h...
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How to Prepare a Standard Operating Procedure
DR. AFSANEH MOTAMED KHORASANI
LIVE : October 20 , 2021 03:00 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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Predicting Product Life with Reliability Analysis Methods
STEVEN WACHS
LIVE : October 20 , 2021 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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6-hr Virtual Seminar: Medical Device Reg...
SUSANNE MANZ
LIVE : October 21 , 2021 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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Creating an Effective Contamination Control & Environmental Monitoring Program
CARL PATTERSON, MS, SSGB, SSBB
LIVE : October 22 , 2021 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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Understanding the Five Pillars of 5S for Operators
DR. GINETTE COLLAZO
LIVE : October 22 , 2021 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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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
PEGGY J BERRY
LIVE : October 25 , 2021 01:00 PM EDT
Life Sciences > Clinical Trial
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : October 26 , 2021 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Data Integrity for medical device development companies & Part 11 under the FDA QSR
DON HURD
LIVE : October 27 , 2021 01:00 PM EDT
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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3-hr Virtual Seminar: Equipment Qualific...
JOY L. MCELROY
LIVE : October 28 , 2021 01:00 PM EDT
Life Sciences > Pharmaceutical

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at ...

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HIPAA Compliance Monitoring and Auditing
MARINA MALIKOVA
LIVE : October 29 , 2021 03:00 PM EDT
Life Sciences > Healthcare | Clinical | Laboratory

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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The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
DENISE WRESTLER, ASQ CQE, CQA
LIVE : October 29 , 2021 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With over 15 years of experience

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HIPAA Privacy and Public Health Exceptions
MARK BRENGLEMAN
LIVE : November 01 , 2021 01:00 PM EST
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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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
SUSANNE MANZ
LIVE : November 04 , 2021 11:00 AM EST
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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Software Development for Medical Device Applications Under IEC 62304
DON HURD
LIVE : November 04 , 2021 01:00 PM EST
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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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
DR. AFSANEH MOTAMED KHORASANI
LIVE : November 08 , 2021 01:00 PM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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