Grey Compliance, Certifications & technology Courses

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Best Practices for Purchasing and Supplier Controls in the Medical Device Industry

JEFF KASOFF

LIVE : January 22 , 2021 01:00 PM EST

Life Sciences > Medical Devices

Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operat...

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Sunshine Act Reporting – Clarification for Clinical Research

DANIELLE DELUCY

LIVE : January 26 , 2021 01:00 PM EST

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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Healthcare Compliance Program: Auditing and Monitoring

MARINA MALIKOVA

LIVE : January 27 , 2021 01:00 PM EST

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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Medical Device Complaints & CAPA

EDWIN WALDBUSSER

LIVE : January 28 , 2021 01:00 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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Extractables & Leachables in Drug Development

DR. STEFANO PERSIANI

LIVE : February 01 , 2021 01:00 PM EST

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmac...

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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

CAROLYN TROIANO

LIVE : February 01 , 2021 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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CMO Supplier Quality Agreements - Comply...

ROGER COWAN

LIVE : February 02 , 2021 03:00 PM EST

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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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

JOY L. MCELROY

LIVE : February 03 , 2021 01:00 PM EST

Life Sciences > Pharmaceutical | Biotchnology | 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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Understanding Sponsor's Responsibilities for an Active IND

GOWRI SUKUMAR

LIVE : February 04 , 2021 01:00 PM EST

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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Remote Auditing of Medical Device Suppliers During Covid-19

SUSANNE MANZ

LIVE : February 05 , 2021 01:00 PM 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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Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements