Conference Spotlight

Key takeaways, industry discussions, and insights from major regulatory conferences.

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Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
Conference Spotlight

Synergy at the Intersection of Data Integrity and Quality Culture

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Conference Spotlight

Inside USDA’s Center for Veterinary Biologics: Part IV, Product Release, International Efforts

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Conference Spotlight

Inside USDA’s Center for Veterinary Biologics: Part III, A Deep Dive on 9 CFR Expectations

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Conference Spotlight

An Inside Look at China’s Regulatory and Drug Approval Processes

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Conference Spotlight

Inside USDA’s Center for Veterinary Biologics: Part II, 21 CFR and 9 CFR Compared

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Conference Spotlight

Inside USDA’s Center for Veterinary Biologics: Part I, Intro to CVB

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Conference Spotlight

Quality Agreements: Part II, How to Write Good Ones

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Conference Spotlight

Health Canada GMP Inspectors Turning to Video, Teleconferencing; Three Case Studies Presented

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Conference Spotlight

Flawed Process Validation, Ineffective Quality Unit Cited in Warning Letter

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Conference Spotlight

Incorrect Specifications, Process Validation Issues at CMO Lead to Adverse Events, Recall

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Conference Spotlight

GMP Inspection Case Study Focuses on Inadequate Deviation Investigations

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Conference Spotlight

Countrywide Import Alert Among Recent FDA Enforcement Activities

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Conference Spotlight

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

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Conference Spotlight

Data Integrity Concerns Discovered in Gene Therapy Product Submissions

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Conference Spotlight

Facility Inspections Among FY2020 CVM Accomplishments

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Conference Spotlight

Update on US/EU MRA: Inspection Reports Being Exchanged

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Conference Spotlight

PIC/S GMP Inspection Reliance Guidance Helps Global Agencies During Pandemic

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Conference Spotlight

Redica Systems Senior GMP Quality Expert Jerry Chapman to Present at PDA Annual

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