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Understanding and Preventing Cleanroom C...
JOY L. MCELROY
LIVE : October 29 , 2020 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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Regulations on Purchasing Controls for Medical Devices
SUSANNE MANZ
LIVE : November 02 , 2020 01:00 PM EDT
Life Sciences > Medical Devices
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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Environmental Monitoring - Setting Accurate Alert and Action Limits
JOY L. MCELROY
LIVE : November 03 , 2020 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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21 CFR Part 11 (electronic records/signatures) Compliance for Computer Systems Regulated by FDA
CAROLYN TROIANO
LIVE : November 05 , 2020 01:00 PM EST
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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How to Write Procedures to Avoid Human Errors
GINETTE COLLAZO, PH.D
LIVE : November 06 , 2020 01:00 PM EST
Life Sciences > Medical Devices

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and...

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Creating an Effective Contamination Control & Environmental Monitoring Program
CARL PATTERSON, MS, SSGB, SSBB
LIVE : November 09 , 2020 01:00 PM EST
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 Combination Products: Navigating the Rules and Regulations
CHARLES H. PAUL
LIVE : November 10 , 2020 01:00 PM EST
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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Understanding Sponsor's Responsibilities for an Active IND
GOWRI SUKUMAR
LIVE : November 10 , 2020 01:00 PM EDT
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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How to Prepare For and Host a FDA Inspection and Respond to 483’s
EDWIN WALDBUSSER
LIVE : November 13 , 2020 01:00 PM EST
Life Sciences > Medical Devices
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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HIPAA Privacy and Public Health Exceptions: COVID-19 and the Coming Coronavirus Pandemic
MARK BRENGLEMAN
LIVE : November 16 , 2020 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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3-hr Virtual Seminar: Understanding Requirements of a Bioanalytical Method Validation
GWENDOLYN WISE-BLACKMAN
LIVE : November 17 , 2020 01:00 PM EST
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...
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Stability Studies & Estimating Shelf Life with Regression Models
STEVEN WACHS
LIVE : November 18 , 2020 01:00 PM EST
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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3-hr Virtual Seminar: Technical Writing ...
JOY L. MCELROY
LIVE : November 19 , 2020 01:00 PM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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4-hr Virtual Seminar: Design Control Pro...
EDWIN WALDBUSSER
LIVE : November 23 , 2020 12:00 PM EST
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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