QSME offers expert guidance through a team of seasoned professionals, dedicated to delivering exceptional training services to keep you and your team informed on the current advancements and regulatory requirements in the pharmaceutical and life sciences field.
Some of the topics we offer training on include:
Marketing Authorization Holder obligations for medicinal products in Europe
GXP-related topics
Regulatory Affairs
Market Access (pricing and reimbursement)
Quality Systems (Standard Operating Procedure writing)
The European General Data Protection Regulation (GDPR)
Our training is designed to be practical, interactive, and engaging, so you can get the most out of your learning experience. We offer both in-person and online training options to suit your needs.
Contact us today to learn more about how QSME can help you and your team succeed in the pharmaceutical industry. We look forward to working with you!
This list includes all new upcoming courses in which you might be interested.
Part II of the advanced course the European Good Distribution Practice (GDP) guidelines focusses on the actions required by wholesalers to prevent the entry of falsified medicines in the distribution chain. Specialist topics such as transport and incoterms are covered.
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During the stand-alone introductory part I of the advanced course the European Good Distribution Practice (GDP) guidelines setting the standards that a wholesale distributor must meet are reviewed in detail. For practical examples, the trainer draws on extensive hands-on GDP experience gained over more than 20 years in various companies.
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The Change Control chapter describes how an organization should deal with important changes. Change Control can relate to all areas covered by the quality control system. A proportionate and effective Change Control system should facilitate a systematic and documented approach and incorporates the principles of quality risk management.
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Deze training is voorbehouden voor magazijnpersoneel van Europese farmaceutische groothandelaars die gebruik maken van door QSME beheerde procedures voor Good Distribution Practice.
Enkel medewerkers die een persoonlijke uitnodiging ontvingen kunnen aan deze training deelnemen.
Deze training is voorbehouden voor de medewerkers van Europese farmaceutische groothandelaars die gebruik maken van door QSME beheerde procedures voor Good Distribution Practice.
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Deze training is uitsluitend bestemd voor medewerkers van Europese farmaceutische groothandelaars die gebruikmaken van door QSME beheerde procedures inzake Good Distribution Practice (GDP) voor psychotrope stoffen.
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During session V of the advanced course the European Good Distribution Practice (GDP) guidelines, participants will be shown how a compliant GDP quality system is developed, improved and maintained.
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Audits, self-inspections, the registration of non-conformities as well as the establishment of Corrective And Preventive Actions (CAPA) are the main topics of part IV of the advanced course on the European Good Distribution Practice (GDP) guidelines.