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 […]
Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If yes, there are 5 essential skills you’ll need to develop to be successful in your employment. The pharmaceutical sector includes medical device manufacturing, biologic medicines, veterinary medicines, medicinal cannabis cultivation and production, and certain nutritional supplements and […]
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 […]
Who conducts GMP audits for pharmaceuticals & other therapeutic goods manufacturing?
Who regulates GMP compliance? List of Regulatory Authorities (Regulators) for GMP manufacturing of pharmaceuticals, biologicals, and medical devices. Well-recognized Government Regulatory Agencies around the world include the following agencies/regulatory bodies: Australian Therapeutic Goods Administration (TGA) Malaysian National Pharmaceutical Control Bureau (NPCB) NPCB – Foreign GMP Inspections document Singapore’s Health Sciences Authority (HSA) Singapore’s Therapeutic Products […]
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 […]
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 […]
EU GMP Online Training | Pharmaceutical Employees
Do you have Pharmaceutical employees who need EU cGMP 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 production facilities overseas (or qualifying a new supplier), or have a long-established production company for pharmaceutical products or medical devices, […]
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 their training course completion) up to date? It’s a known challenge in training sectors that annual training BUDGETS can be difficult to match with employee training NEEDS at times. Yet […]