FDA Inspections

May
27

Get ready for an Audit

Get ready for an audit (how to train your employees) Need to get ready for an audit? How do you ensure your organisation is ready for an audit? Do your employees know how to properly respond to an Auditor’s questions? Or was your last mock GMP audit (or internal quality audit/self-inspection) a disaster? If you’re […]

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May
17

Remote Auditing Guidelines

Remote Auditing Guidelines and Procedures for Remote Audits (ICT, Security) Remote Auditing Guidelines: 10 Commandments for Conducting Remote Audits and offsite inspections Frequently asked questions about Remote Auditing techniques, procedures and guidelines FAQ1: Are remote audits as effective as onsite audits and site inspections? The success of a remote audit depends on numerous factors, including […]

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Oct
27

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 other medical devices, medical-use software offers potential benefits to patients. SaMD can save lives by improving diagnostic capacities, monitoring treatment efficacy, and guiding critical-care decisions. Review the online GMP compliance course for SaMD designers, medical-use software manufacturers […]

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Sep
14

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 relate to drug safety through GCP (clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting). These courses cover pharmaceutical development quality management systems (QMS) and quality risk management (QRM), drug approval processes, […]

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Apr
14

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 supply chain risks are particularly heightened during deadly pandemics, such as we’re seeing with Covid19. Medical supply shortages leave us vulnerable to substandard products and falsified medications entering our supply chains. If substandard or fake medical products […]

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Feb
25

GMP Training: Annex 2B Biological Products for Human Use

GMP regulations (PIC/S guidelines) for Biologicals manufacturing were covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use). Note: Annex 2 was updated in PIC/s version 15 – to Annex 2A (ATMPs) with Annex 2B covering Biological medicines. ** Note – the new course on Annex 2A (ATMPs) and for Annex […]

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