mygmptraining
Shamik (Sam) Pandit
Publishing Details
About This Podcast
Regulations tell you what to do, but 40 years of experience tells you how to do it right the first time. Join us on mygmptraining as we pull back the curtain on FDA compliance and quality systems. Whether you’re a seasoned Quality Director or a newcomer to the lab, we provide the insights, pitfalls, and "war stories" necessary to build a culture of compliance that stands up to any audit.
#GxPTraining #PharmaCompliance #QualitySystems #Biologics #RegulatoryAffairs #FDACompliance #QualityAssurance #PharmaceuticalManufacturing #LifeSciences #GMP #GLP #GCP #PharmaExpert #QualityManagement #AuditReady #BiotechCompliance
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Recent Episodes
S2026E5 High Purity Water System
This episode of the Deep Dive podcast navigates the complex regulatory and engineering landscape of pharmaceutical water systems, using the FDA’s July 1993 Inspection Guide as a foundational…
S2026E4 21 CFR 211 -Subpart B - Organization and Personnel
This presentation outlines the regulatory requirements for pharmaceutical organization and personnel as defined by 21 CFR Part 211, Subpart B. It emphasizes the critical role of the Quality Control…
S2026E3 Obstructing FDA inspections
This episode outlines official FDA guidance regarding the specific behaviors that constitute the obstruction of drug or device inspections. Under federal law, if a facility delays, denies, limits, or…
S2026E2 Process Validation - A Science based approach for Pharmaceutical Quality Assurance
This podcast outlines the essential standards for process validation within the pharmaceutical and biologics industries. It establishes a three-stage lifecycle approach that includes process design,…
S2026E1 The Case of the Failed Batch
This episode talks about the FDA-mandated guidance document for managing out-of-specification (OOS) results within the pharmaceutical industry. The guidance emphasizes a rigorous two-phase…
Frequently Asked Questions
mygmptraining has published 5 episodes since January 2026, covering topics in Business, Courses.
mygmptraining is currently highly active with new episodes monthly. Average episode length is 17m.
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