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…
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…
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…
Does my product require FDA approval? FDA Pre-Approval Requirements
How can you tell if your product needs pre-approval from the FDA before you can market it to…
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