MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)
Top 10 MHRA GMP Audit deficiencies (2019 – 2020 analysis) Summary article for Education Purposes only. If you are facing a GMP audit by the MHRA, you’ll want to ensure ALL of your quality systems are fully compliant with current Good Manufacturing Practice (cGMP). That noted, which components of your pharmaceutical or medical device quality […]
HVAC system specifications and requirements: pharmaceutical manufacturing
When it comes to HVAC system specifications and requirements for pharmaceutical facilities – including cleanroom designs – getting your HVAC system right is crucial for product quality and GMP compliance. If your pharmaceutical facility architects (or construction managers) do not fully understand GMP, you’re risking product contamination issues and future GMP inspection findings (GMP audit […]
Cannabis Cultivation Training: 2 Convenient Options
Cannabis Sector Insights and Cultivation Training Cannabis Sector Speaker Presentations from the Global and Asia-Pacific Medicinal Cannabis Conference For those of you who missed the world-class Australian Medicinal Cannabis Conference (#AMCC) in 2020, there are two (2) options available to you, your potential investors, and your operational teams in need of cultivation training expertise and regulatory […]
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 […]
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, […]
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 […]
Cannabis Industry Security: Training
Are you a security guard, currently out of work due to Covid-19 changes to the entertainment industry? Have you thought about applying for jobs in the Medicinal Cannabis Security Industry? Or perhaps studying to become an expert in Security Services for this sector? Before you embark on your new career path, you’ll need to have […]
Medicinal Cannabis Workplace Health and Safety Course
Medicinal Cannabis Industry: Workplace Health and Safety Training Our new online training courses for the global Cannabis Sector include a Medicinal Cannabis Industry Overview, Cannabis Workplaces and Zones, Workplace Health and Safety, Security Requirements, Botany Basics, and Cultivating Medicinal Cannabis. There are 6 newly-released eLearning modules in Series 1 plus 6 additional advanced crop care […]
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 […]
Pharmaceutical Water For Injection
What is Water For Injection (WFI)? How does WFI relate to different types of Pharmaceutical Water Quality in pharmaceutical manufacturing settings? And what do engineers and water supply system designers need to know when designing feed-supply water systems, including pre-treatment processes, in PICS GMP regulated manufacturing sectors? These questions are answered in our online training […]
FAQs: e-Learning Development Questions
This article reviews FAQs: e-Learning Development questions and answers. We’ll also explore comparisons between Webinars vs E-learning courses — and comparisons to Podcasts — as alternatives to classroom-based delivery methods. Alternatives to classroom-based delivery methods Online Training Development and Course Design Basics Education technologies, digital delivery requirements and e-learning hosting costs: FAQs and e-Learning development […]