The GMP Insider – Details, episodes & analysis

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The GMP Insider

Tushar Arora

Science

Frequency: 1 episode/4d. Total Eps: 74

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 Affairs, GMP Insider helps you stay compliant, confident, and ahead in an ever-evolving pharmaceutical industry.

New episodes deliver:
• GMP best practices
• Audit readiness strategies
• Real compliance case studies
• Industry trends and updates
• Expert tips from quality professionals

From batch to patient — quality is everything.

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https://www.linkedin.com/in/tushar-a-926382161
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https://www.linkedin.com/in/tushar-a-926382161Watch
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https://www.youtube.com/@TheGMPInsider
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RSS feed quality

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Score global : 59%

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Why FDA Rejects Your CAPA: 5 CAPA Effectiveness Failures Explained

Wednesday, October 21, 2026 • Duration 13:53

Nearly nine out of ten human-drug warning letters include at least one inadequate CAPA response. Your corrective action plan is the single most rejected document in FDA enforcement — and it's not for lack of effort. Marcus and Priya count down the five CAPA effectiveness failures that keep quality teams in warning-letter territory: fixing the event instead of the system, root causes that stop at human error, CAPAs closed with no proof they worked, CAPAs written to answer the 483 instead of fixing the system, and no trending — so the failure recurs.
• Why CAPA is the most rejected document in FDA enforcement• Failure one: corrective action with no preventive action — fixing the event, not the system• Failure two: root causes that stop at "human error"• Failure three: closing a CAPA with zero evidence the change worked• Failure four: CAPAs written to answer the 483 observation, not to fix the system• Failure five: no trending — the same failure recurs, and FDA cites recurrence• The Monday-morning CAPA playbook that survives an investigator
New episodes every Monday and Wednesday — follow The GMP Insider so you never miss one.Connect with Tushar Arora on LinkedIn: https://www.linkedin.com/in/tushar-a-926382161Watch on YouTube: https://www.youtube.com/@TheGMPInsider
Produced with AI assistance.

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Why FDA Rejects Your CAPA: 5 CAPA Effectiveness Failures Explained

Wednesday, October 21, 2026 • Duration 13:53

Nearly nine out of ten human-drug warning letters include at least one inadequate CAPA response. Your corrective action plan is the single most rejected document in FDA enforcement — and it's not for lack of effort. Marcus and Priya count down the five CAPA effectiveness failures that keep quality teams in warning-letter territory: fixing the event instead of the system, root causes that stop at human error, CAPAs closed with no proof they worked, CAPAs written to answer the 483 instead of fixing the system, and no trending — so the failure recurs.• Why CAPA is the most rejected document in FDA enforcement• Failure one: corrective action with no preventive action — fixing the event, not the system• Failure two: root causes that stop at "human error"• Failure three: closing a CAPA with zero evidence the change worked• Failure four: CAPAs written to answer the 483 observation, not to fix the system• Failure five: no trending — the same failure recurs, and FDA cites recurrence• The Monday-morning CAPA playbook that survives an investigatorNew episodes every Monday and Wednesday — follow The GMP Insider so you never miss one.Connect with Tushar Arora on LinkedIn: https://www.linkedin.com/in/tushar-a-926382161Watch on YouTube: https://www.youtube.com/@TheGMPInsiderProduced with AI assistance.

The GMP Insider – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Spotify

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Related Shows Based on Content Similarities

Related Shows Based on Content Similarities

Apple Podcasts

Spotify

The GMP Insider – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Spotify

Shared links between episodes and podcasts

LinkedIn2

YouTube1

RSS feed quality and score

Publication history

Latest published episodes

Similar podcasts and content

Related Shows Based on Content Similarities

Related Shows Based on Content Similarities

LinkedIn2

YouTube1

Apple Podcasts

Spotify