FDA CFR Part 800 & Part 820 for Medical Devices
Course duration: Allow 1.5 to 2 hours to complete this course.
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Medical Device Recalls – Early Alerts System (FDA Pilot Expansion)
On 29 September 2025, the FDA announced that the pilot program for rapid medical device recall communications (the ‘Early Alerts system’ for device recalls) was being expanded. Medical Device Recalls: Early Alert System The FDA’s Early Alert System for medical device recalls was designed to minimise delays between FDA awareness and communication of recalls to…
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GMP for Herbal Medicines
Why is compliance with GMP for Herbal Medicines so important? Plant-based medicinal products often pose additional patient risks compared to many other medicine types, e.g., if a medicine contains inconsistent percentages of active ingredients, or is contaminated/adulterated with moulds or bacteria. In addition to patient safety concerns, improper handling or disposal of these products (including…
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Change Control Processes
Allow 1 to 2 hours.
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Validation Training
Validation Training for Life Sciences & Pharmaceutical Industry Professionals Personnel involved in qualification, validation & verification activities should be appropriately qualified, trained and experienced to fulfil their responsibilities. In this article, we’ll review online Qualification & Validation Training Courses including Certificate GMP courses from onlinegmptraining.com, and Pharmaceutical Manufacturing Fundamentals training, which is suitable for validation…
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GMP Education Programs
GMP Education Programs: Why is repeated GMP training (as part of your PQS) so important for sustaining a “GMP compliance culture?:
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Prevention of Falsified Medicinal Products
Allow 1 to 1.5 hours.
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Understanding cGMP Certification
For therapeutic goods to reach patients and consumers, they must be shown to meet Good Manufacturing Practices (GMP). GMP Certification is one such means of demonstrating this compliance. cGMP Certification, representing ‘current Good Manufacturing Practice Certification), is another term referred to by Regulatory Authorities in various jurisdictions, e.g. the US FDA. In this blog we…
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Top 10 GMP Courses
What are the “Top 10 GMP Certificate Courses” you need to complete in 2023 if you’re one of the following life science industry professionals? Top 10 GMP Courses You’ll Need This Year Here are the ‘Top 10 GMP Courses’ (GxP & GMP education topics) recommended for you to complete in 2023 to stay on track…
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ISO 14971: Risk Management for Medical Devices
Course duration: Allow 2 to 3 hours to complete this course.
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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.
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ISO 13485 – Quality Management Systems
Course duration: Allow 2 to 4 hours to complete this course.
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