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.
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.
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 …
FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Auditing FAQs: Guidelines for Offsite Inspections
Procedures for Remote Inspections (virtual inspections) including ICT and Security Auditing Guidelines and Auditor Training Courses 10 Commandments…
Software as a Medical Device (SaMD)
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with…
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…
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…
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