Introduction to FDA CFRs 210, 211 and CFRs 800 & 820 (Training Bundle)
Course duration: Allow approximately 4 to 6 hours to complete all 4 courses in this training bundle.
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FDA CFR 800 & CFR 820 for Medical Devices
Course duration: Allow 1.5 to 2 hours to complete this course.
GMP Education Programs
GMP Education Programs: Why is repeated GMP training (as part of your PQS) so important for sustaining a “GMP compliance culture?:
Prevention of Falsified Medicinal Products
Allow 1 to 1.5 hours.
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…
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…
GxP Computerised Systems
Course duration: Allow 2 to 4 hours to complete this course.
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 13485:2016 Training – Quality Management Systems for Medical Devices
Course duration: Allow 2 to 4 hours to complete this course.
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PIC/S GMP: Are mock recalls required?
GMP Education Topic: Pharmaceutical Product Recalls Mock recalls help employees prepare for a recall. They also indicate to Regulatory Authorities that your recall procedures are fit for purpose and that your quality systems are under control. Regulations for Recalls of Medicines and Medical Devices Medical Industry Recall Guidance Complaint management and recall requirements for defective…
Recalls of Therapeutic Goods
Course duration: Allow 3 to 5 hours to complete this course.
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