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 in pharmaceutical manufacturing and other therapeutic goods production?
Who regulates GMP compliance? In today’s blog supporting the GMP Basics training series, we’ll answer questions relating to “who regulates compliance GMP?” We’ll provide a brief overview and list of Regulatory Authorities that conduct GMP audits in pharmaceutical manufacturing sectors, medical devices manufacturing, blood and tissue products and other laboratories/bio-science industries. We will also discuss […]
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 […]
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 […]
Adaptive e-Learning: Embracing Content Change
In our latest Online Learning Trends (2020) article – Part 2: Virtual Reality Trends, we noted the increasing trend for adaptive e-learning modules. Why your e-learning designers need to embrace content change (adaptive e-learning). The premise of adaptive e-learning is two-fold. The key features of adaptive e-learning are (1) learner-centric content delivery and (2) artificial […]
Webinars vs e-Learning: Pros and Cons
Is hosting a webinar better than creating online training courses (e-Learning modules)? Should you host a webinar series dependent upon your presenter(s) — or devote your time to developing a repeatable online training course, instead? This blog is second of two (2) articles in a series comparing webinars to e-learning modules and podcasts. By Connie […]
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 […]
GMP Basic Training Pharma – Online Courses
GMP basic training (Pharma) online courses are an option for ensuring employees stay up to date and compliant with GMP knowledge and Course Certificate requirements. GMP Training Options for Pharma: Certificate Courses are available at affordable prices. They provide near-instant access to help new or returning employees meet their GMP training and course certificate requirements. […]
eLearning vs Classroom GMP Training Comparisons
Moving forward with the knowledge revolution, GMP eLearning has hit the mainstream. While some GMP compliance topics remain best suited for customised classroom instruction, GMP elearning provides employers with a convenient, economical way to keep contractors and employees up-to-date on GMP compliance matters. Certificate GMP training courses and GMP refresher courses are available-24/7, at a […]
Blended Learning Theory, 70:20:10 and ‘the forgetting curve’: GMP Training
Blended Learning Theory, 70:20:10 and ‘the forgetting curve’ – how it impacts your GMP training for employees and why online GMP training options can help knowledge retention. Definition of ‘the forgetting curve’ and how blended learning theory | GMP If you’re investigating GMP online training options versus classroom instruction, you may have already heard about […]