Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit…
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…
Remote Inspections (Offsite Inspections): Auditing Guidelines
Procedures for Remote Inspections (virtual inspections) including ICT and Security Remote Inspections & Offsite Auditing Guidelines & Training…
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…
Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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