E-DRUG: Online Course: GMP & Inspections for Medicines & Healthcare Products 5 Oct-16 Nov
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Dear all,
We are happy to announce a new online course session on Good Manufacturing Practices (GMP) open for registration, of which you will find a short description below:
Cost: 450 Euros
Level of effort: 4 to 6 hours per week
Registration deadline: 5th October 2015
Certificates and e-badges will be awarded upon successful completion
For more information and registration, visit the i+ academy page
www.iplusacademy.org
The lack of a qualified human resources base in the manufacturing sector of medicines and other healthcare products is a big challenge, especially in low and middle income countries. In particular, there is need for skilled personnel for quality units (quality assurance & control) and other GMP relevant areas. Costs for bringing in experts from abroad are high.
Combined with other challenges, local manufacturers often struggle to compete and even survive. Not being in line with international quality standards, they are prevented from passing WHO prequalification, participating in international tenders, and entering international markets. Moreover, the National Medicines Regulatory Agencies (NMRAs) of these countries experience a shortage too of qualified staff in GMP, GMP inspection and dossier evaluation. This creates difficulties for NMRAs to enforce internationally acceptable regulatory requirements (including GMP standards) thereby preventing the availability of affordable quality generics for the majority of their low income population groups.
This e-learning course introduces Good Manufacturing Practices and GMP inspections for medicines and healthcare products, focusing on WHO GMP standards and requirements as one of the major GMPs. Course participants will develop an understanding of the importance of implementing GMP in their daily working routine, starting from personnel hygiene to quality documentation and many other GMP requirements. While the main focus in on medicines, an extra session of the course introduces the requirements for healthcare products, specifically female condoms.
In the end, these capacity building measures in the area of GMP and GMP inspection will make the local manufacturing sector and the national regulatory authorities better equipped for production and regulation of quality assured essential medicines and healthcare products, in line with national and international standards.
Thank you
Adebayo Adekola
address: Polanerbaan 11, 3447 GN, Woerden, The Netherlands|
www.iplussolutions.org
i+academy: www.iplusacademy.org
email: Aadekola@iplussolutions.org