Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
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ISO 14971: Risk Management for Medical Devices
Course duration: Allow 2 to 3 hours to complete this course.
Are you ‘recall ready’ according to the FDA?
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
ISO 13485 Training – Quality Management Systems for Medical Devices
Course duration: Allow 2 to 4 hours to complete this course.
Medicine Supply Shortages
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
Recalls of Therapeutic Goods
Course duration: Allow 3 to 5 hours to complete this course.
Complaints Management
Course duration: Allow 1.5 to 2 hours to complete this course.
10 Key Steps for Managing a GMP Compliance Training Program
Are you an experienced trainer, but new to the Pharmaceutical industry and cGMP compliance training programs? Perhaps you are a business owner – or recently promoted into a Quality Management role – with responsibilities for training new hires and long-term employees? If you’re looking for recommendations for best-practice cGMP training, this article is for you….
CAPA – Corrective and Preventive Actions
Course duration: Allow 1.5 to 2 hours to complete this course.
FDA Warning Letters – CAPA
FDA Warning Letters for cGMP compliance issues relating to CAPAs If you’re a Pharmaceutical business owner or Quality Manager, you know this all too well — that your deviation management records & CAPA system will be scrutinised during your next GMP compliance audit. Auditors and FDA Inspectors are all but guaranteed to delve deeply into…
Deviations and Non-Conformances
Course duration: Allow 1.5 to 2 hours to complete this course.
Classroom Training | e-Learning Costs | online courses completion | online training completion ratios | Training Assessments Best Practice
Online Learning During the Pandemic
Online learning during the pandemic – a practical solution to GMP training requirements. The education industry was particularly impacted by Covid-19; and by the 2nd quarter of 2020, most face-to-face training sessions were put temporarily on hold. Temporarily on hold turned to indefinitely on hold; as the pandemic continued to wreak havoc around the globe….
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