FDA Audit

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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Feb
25

GMP Training: Annex 2 Biological Products for Human Use

GMP regulations (PIC/S guidelines) for Biologicals manufacturing are covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use). Ensuring the safety of employees, clinical researchers, vaccination testing employees, hospital workers and the public is increasingly important given the current climate of the rapidly-spreading coronavirus (and COVID-19 outbreaks). If you haven’t updated your […]

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Oct
21

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 audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions. Yet TGA and […]

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Sep
19

Industry Updates: PDA and FDA Joint Regulatory Conference

Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case? It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top […]

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Aug
06

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 the public? This blog gives you a general idea of the types of products and additives that require pre-approval from the FDA prior to marketing (going to market). You’ll need to consult the FDA and visit the […]

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