Tushar Arora
The GMP Insider
GMP Insider is your go-to podcast for practical insights into pharmaceutical quality, Good Manufacturing Practices (GMP), and regulatory compliance. Designed for quality professionals, manufacturing teams, and pharma leaders, this show breaks down complex regulations into clear, real-world guidance. Each episode explores topics like audits, CAPA, data integrity, quality systems, validation, and global regulatory expectations — all with a focus on protecting patients and building strong quality cultures. Whether you work in Quality Assurance, Quality Control, Manufacturing, or Regulatory Affair...
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Épisodes
Data Integrity in GMP: From Trust to System Control 30.01.2026 16:12
Data integrity issues rarely begin with bad actors — they usually start with convenience. In this episode, we examine how FDA auditors identify loss of system control through everyday practices like shared logins, manual entries without review, and backdating documentation. These shortcuts weaken compliance and raise serious red flags during inspections. Learn how regulators evaluate whether...
What Mickey Mouse Clubhouse Teaches About Root Cause Analysis 27.01.2026 20:30
This episode presents Deviation and Root Cause Analysis through an unconventional lens: Mickey Mouse Clubhouse . By mapping cartoon problem-solving steps to pharmaceutical Quality practices, we discuss proper deviation documentation, risk assessment, investigation techniques, and CAPA effectiveness. Ideal for: • QA professionals • Manufacturing and Engineering teams • Students enter...
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