TGA GMP Audit

Sep
14

Good Clinical Practice (GCP) Inspections Program

New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com relate to drug safety through GCP (clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting). These courses cover pharmaceutical development quality management systems (QMS) and quality risk management (QRM), drug approval processes, […]

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Apr
14

Medical Supply Chain Risks: Vulnerabilities and the Importance of GMP

Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon.  But medical supply chain risks are particularly heightened during deadly pandemics, such as we’re seeing with Covid19. Medical supply shortages leave us vulnerable to substandard products and falsified medications entering our supply chains. If substandard or fake medical products […]

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Feb
25

GMP Training: Annex 2 Biological Products for Human Use

GMP regulations (PIC/S guidelines) for Biologicals manufacturing are covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use). Ensuring the safety of employees, clinical researchers, vaccination testing employees, hospital workers and the public is increasingly important given the current climate of the rapidly-spreading coronavirus (and COVID-19 outbreaks). If you haven’t updated your […]

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Feb
14

Adaptive e-Learning: Embracing Content Change

In our latest Online Learning Trends (2020) article – Part 2: Virtual Reality Trends, we noted the increasing trend for adaptive e-learning modules.  Why your e-learning designers need to embrace content change (adaptive e-learning). The premise of adaptive e-learning is two-fold.  The key features of adaptive e-learning are (1) learner-centric content delivery and (2) artificial […]

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Oct
21

Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings

Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions. Yet TGA and […]

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Sep
19

Industry Updates: PDA and FDA Joint Regulatory Conference

Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case? It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top […]

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