FDA and EU GMP

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
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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Jul
18

Who conducts GMP audits in pharmaceutical manufacturing and other therapeutic goods production?

In today’s blog supporting the GMP Basics training series, we’ll answer questions relating to “who conducts GMP audits in pharmaceutical manufacturing sectors, medical devices manufacturing, blood and tissue products and other laboratories/bio-science industries?”.   We will discuss the value of GMP compliance, as well as widely-recognized Regulatory Agencies responsible for GMP (PIC/S) audits in various regions […]

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Jul
05

EU GMP Online Training | Pharmaceutical Employees

Do you have employees who need EU GMP training, including validation, record-keeping (GDocP) and GDP? Or perhaps you’re exploring current job opportunities and need to be sure you’re up to date?  Whether you’re starting-up an overseas production facility, or have a long-established production company for complementary medicines (CBD), common pharmaceuticals or new medical devices, you’ll […]

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Jun
25

10 Ways to Cut Your Training Costs for GMP

How do you match the average training budget with your employee training needs?  And how can you best keep your employees’ GMP certificates (evidence of training course completion) up to date? Annual training budgets are hard to match to employee needs at times.  Yet GMP audit findings often include a gap in training evidence.  Our […]

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