Mon 22 Mar 2021 @ 13:25
grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of a new suite of courses on validation of manufacturing equipment, services, systems and processes.
Validation is vitally important in the pharmaceutical, biotechnology, dietary supplement, and medical device industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. The new suite of courses provides an introduction to validation, and practical advice on equipment commissioning and qualification, equipment cleaning validation, and computer systems validation.
All involved in the manufacture of medicines and healthcare products need to understand the principles and practice of validation, as set out in these courses. In particular, the courses provide essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.
The courses are:
- VAL01: Introduction to Validation
- VAL02: Validation Plans and Documentation
- VAL03: Commissioning and Installation Qualification
- VAL04: Operational and Performance Qualification
- VAL05: Equipment Cleaning Validation
- VAL06: Computer Systems Validation, Part 1: Planning
- VAL07: Computer Systems Validation, Part 2: Implementation
Wed 1 Jul 2020 @ 20:50
How often do we see grand developments, in healthcare and other spheres, disrupted by problems affecting major IT projects that are essential to the plans? UK healthcare professionals won’t need to be reminded of the failure to achieve a single electronic system of patient records for the whole of the National Health Service, for example.
Currently, two sweeping changes to the regulation of medicinal products and medical devices in Europe are stalled, in large part by IT problems. To be fair, reasons for the postponement of the implementation of the EU Medical Device Regulation (MDR) until May 2021 include the Covid-19 pandemic as well as delays to the EUDAMED database. The postponement has brought relief to many medical device companies who were fearful that inadequate access to notified bodies designated in compliance with the MDR would cause crippling delays to the certification of their products.
It is no surprise, however, that the long delay to the implementation of the EU Clinical Trial Regulation, enacted in 2014, can be blamed squarely on the development of the portal, now known as the Clinical Trials Information System, that is essential to the regulation. Implementation is now expected sometime in 2021, but we’ve had great expectations before ….
We will of course keep our clinical trials and medical device modules up to date with developments.
Watch this space!
Tue 14 Apr 2020 @ 18:07
Understanding the regulatory and approval process to ensure acceptance to the market is a crucial part of any product design and manufacture.
Covid-19 has put huge pressure on the world's health system to cope. Many organisations have put their design and manufacturing resources to work on producing medical devices; there is no doubt that this pressure will not be subsiding any time soon, and tragically many lives have already been lost.
We are making our MD01 Introduction to the Regulation of Medical Devices available at no cost* to any organisation or individual who is requiring to gain this knowledge in the world wide fight against this latest deadly coronavirus. If this knowledge can accelerate any organisations concept to delivery process, even by one day, it may save one or multple lives.
Delivered via our cloud based LMS, you can apply for bulk learner set up by contacting us at [email protected]
For individuals, you can simply "buy" the course by adding it to your basket for free checkout.
Let's all work together to fight this pandemic and look forward to better times for the whole of humanity.
*Our normal terms and conditions apply. This offer is provisionally open until the end of June 2020 but subject to change at any time
Zenosis® is a brand of grapl Ltd., an eLearning and digital media company registered in Scotland, UK.
Mon 4 Mar 2019 @ 11:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of its first course on medical devices, MD01: An Introduction to the Regulation of Medical Devices.
The course provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market products in Europe and the USA. It explains what medical devices are and gives examples of the various types. It outlines the principles of their regulation and the criteria for placing them on the market, and it identifies major players in regulation worldwide. It then outlines prominent characteristics of the regulation of medical devices in the USA and in Europe.
This module provides essential training for all personnel concerned with the development, regulatory compliance, or marketing of medical devices. It is especially suitable for induction training of entry-level staff.
Tue 14 Nov 2017 @ 11:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course, PV07: Good Pharmacoepidemiology Practice.
Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This module will help those who plan and conduct such research, and analyse and report the findings, to follow good practice.
Staff working in drug safety and pharmacovigilance or clinical research departments of pharmaceutical and biotechnology companies will benefit from this module. It will also be of value to healthcare professionals.