Latest news…
EU extends grace period for transition to Medical Device Regulation
New course on good practices (GxP)
New courses on clinical trial safety reporting released
Fifty courses now available from Zenosis
New courses on clinical research under the EU Clinical Trials Regulation released
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News
New course: Good Documentation Practice
Fri 29 May 2015 @ 15:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course: Good Documentation Practice.
Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products.
In this module the crucial importance of GDocP is emphasised, and five principles that underpin it are identified. The functions of the various types of documents that are used are explained, and descriptions are given of how they should be created and controlled. Finally, requirements for record keeping are set out – how data are to be entered into records, corrected if necessary, and how records must be retained.
More Zenosis courses approved by Royal Society of Chemistry
Thu 21 May 2015 @ 8:43
Zenosis, the leading provider of eLearning for the medicinal products industry, is pleased to announce that a further three of its courses have been awarded Approved Training status by the UK’s Royal Society of Chemistry. The courses are:
- Preparing Submissions in the Common Technical Document (CTD) Format
- Electronic Common Technical Document (eCTD)
- Registration of Monoclonal Antibodies
Approval by the Society identifies good quality training that supports members in their Continuing Professional Development (CPD). The Society’s approval process is one of peer review, involving assessment against set criteria by members expert in their field.
Continuing Professional Development refers to the learning activities through which professionals develop their abilities and ensure that they remain competent and increasingly effective. CPD is encouraged in all professions and is formally required in some. It may be otherwise known as Continuing Professional Education (CPE) or, in the context of medicine, Continuing Medical Education (CME).