FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Procedures for Remote Inspections (virtual inspections) including ICT and Security Auditing Guidelines and Auditor Training Courses 10 Commandments…
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with…
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical…
Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP…
How can you tell if your product needs pre-approval from the FDA before you can market it to…
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