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 […]
Good Documentation Practices (GDocP) and GDP Training
Your GMP documentation compliance is a key requirement for passing a TGA Audit or FDA Audit. Good documentation practices are also imperative for passing other industry-specific quality assurance inspections (PICS/GMP compliance audits). This includes ISO9001-2015 standards and industry-specific ISO standards for laboratories, medical devices and pharmaceutical products. If your record-keeping is not up to current […]
Medicinal Cannabis Seminar | Understanding GACP and GMP
Learning and Development Director Maria Mylonas, arguably the world’s best GMP trainer based on hundreds of GMP and GxP training reviews, was invited to be a Guest Speaker at combined Schimadzu/Scitek Medicinal Cannabis Seminars being held in August. Learn more about entering the medicinal cannabis industry in Australia or New Zealand. Here’s the information for […]
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 […]
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 […]
10 Ways to Cut Your Training Costs for GMP
How can you best keep your employees’ GMP training up to date yet keep your training and development budget under control? In today’s top online training and development blog, we discuss 10 ways to cut your training costs for GMP training requirements. We review affordable GMP training methods and cost reduction strategies best suited for the […]
Mindset 4.0 Masterclass: Innovation, Agility and Sustainable Manufacturing
How important is mindset when it comes to learning something new? And what is the difference between a fixed mindset vs a growth mindset? Introducing the Mindset 4.0 Masterclass for manufacturing and pharmaceutical business sectors. In this 1-day Masterclass being held in Melbourne after the annual GMP & Engineering Forum, we review the value of […]
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. […]