E-DRUG: i+solutions e-course "Basic principles of GMPs and GMP Inspections"
i+solutions is pleased to announce the opening of registration to our e-course
"Basic Principles of Good Manufacturing Practices and GMP Inspections"
Dates: 02 March - 29 March 2015
Level of effort: 4 to 6 hours per week
Cost: 450 euros
Registration deadline: 25 February 2015
Certificates and e-badges will be awarded upon successful completion
Register on www.iplusacademy.org<http://www.iplusacademy.org/>.
What is the course about?
The lack of a base of qualified human resources in the pharmaceutical
manufacturing sector is one of the challenges for pharmaceutical industries,
especially in low and middle income countries. In particular, there is need for
skilled personnel for quality units (quality assurance, quality 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 the 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 provides an introduction to
the basic principles of GMP and GMP inspection, 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. An extra session of the course introduces the
requirements for medical devices such as female condoms. In the end, these
capacity building measures in the area of GMP and GMP inspection will make the
local pharmaceutical sector, including the NMRAs, better equipped for
production and regulation of quality assured essential medicines in line with
national and international standards.
Who is the course meant for?
The course is designed mainly for individuals and organisations in GMP-relevant
areas and GMP inspectorates, both those with professional experience who want
to deepen and update their knowledge, as well as young professionals who want
to prepare intensively for their tasks.
What topics will be covered?
Development of medicines regulation; GMP and other related good practices;
quality management; special focus: medical devices; personnel, organisation and
training; sanitation and hygiene; premises; equipment; materials; good
practices in production and quality control; qualification and validation; GMP
requirements for documentation; complaints and recalls; self-inspection and
quality audits; introduction to pharmaceutical inspections; the role of the
inspector; types of GMP inspections; inspections and inspection report.
What will you learn?
After having successfully completed the module, participants will be able to:
1. Appreciate the importance and need for good manufacturing practices in
the pharmaceutical industry.
2. Be familiar with the development of medicines regulation.
3. Understand the basic requirements in GMP, including procedural,
organizational and infrastructural aspects.
4. Have gained basic information on requirements for medical devices such as
female condoms, as a special focus.
5. Critically analyse and implement basic GMP requirements in their daily
working routine in pharmaceutical manufacturing environment.
6. Understand the need for, and the benefit of pharmaceutical inspections.
7. Be familiar with different types of GMP inspections
8. Interpret and discuss the role of GMP inspectors
9. Understand the inspection process and structure of an inspection report
How are we going to teach and learn?
The course is taught online on i+academy, our e-learning platform, by expert
facilitators. The interactive course materials are presented sequentially under
the guidance of the facilitator who assists participants, answers questions and
stimulates discussions. Lessons are complemented and enlivened by online
activities such as discussion forums, quizzes, and assignments. The course is
accessible from anywhere at any time and allows participants easy and regular
interactions with the course facilitator and other participants during the
Senior training coordinator
Monday, Wednesday, Friday
Universal Access to Essential Medicines
phone: +31 0348 748 722
address: Polanerbaan 11, 3447 GN, Woerden, The Netherlands