Regulatory Compliance Kurse

Die neue Maschinenverordnung (EU) 2023/1230 verändert die Anforderungen an die CE‑Kennzeichnung für Maschinenhersteller und Systemintegratoren grundlegend. Gleichzeitig bringen Regelwerke wie der Cyber Resilience Act (CRA) und der EU AI Act zusätzliche Verpflichtungen hinsichtlich Software, Cybersecurity und Risikomanagement mit sich.Dieses 1‑tägige Praxistraining vermittelt ein strukturiertes und anwendungsorientiertes Verständnis der CE‑Kennzeichnung im aktuellen EU‑Rechtsrahmen. Sie lernen, wie Sie relevante Richtlinien und Verordnungen identifizieren, den Geltungsbereich Ihrer Produkte definieren und Konformitätsbewertungsverfahren effizient umsetzen.Der Fokus liegt auf der praktischen Umsetzung: Sie erhalten konkrete Ansätze, um CE‑Compliance in Entwicklungs‑ und Konstruktionsprozesse zu integrieren, Risiken zu minimieren und den reibungslosen Marktzugang innerhalb der EU sicherzustellen.

Der Cyber Resilience Act (CRA) (EU) 2024/2847 sowie die Cybersicherheitsanforderungen der Funkanlagenrichtlinie (RED, Artikel 3.3(d)) verändern die regulatorischen Anforderungen an vernetzte und softwarebasierte Produkte in der EU grundlegend.Dieses intensive 1‑Tages‑Training vermittelt Ihnen ein praxisnahes und strukturiertes Verständnis der Cybersicherheitsanforderungen für Produkte im EU‑Rechtsrahmen. Sie lernen, wie Sie relevante Anforderungen identifizieren, den Geltungsbereich Ihres Produkts bestimmen und Secure‑by‑Design‑Prinzipien entlang des gesamten Produktlebenszyklus umsetzen.Der Fokus liegt auf der konkreten Umsetzung: Sie erhalten praxisorientierte Ansätze, um regulatorische Vorgaben in Engineering‑ und Compliance‑Prozesse zu überführen, Dokumentationsanforderungen effizient zu erfüllen und Schwachstellen systematisch zu managen. So vermeiden Sie Compliance‑Lücken, reduzieren Risiken und sichern den Marktzugang innerhalb der EU.

Die Good Distribution Practices (GDP) EU-Leitlinie 2013/C 343/01 verlangt, dass Sie, als verantwortliche Personen, Ihre Kompetenzen bei der guten Vertriebspraxis durch regelmäßige Fortbildung auf dem aktuellen Stand halten. Das halbtägige Training der SGS baut auf dem Grundlagen-Seminar GDP auf, informiert über neue Entwicklungen und bietet eine Plattform für den Austausch zu den Herausforderungen der betrieblichen Praxis. Dabei wird Grundlagenwissen zu Audits und zielführendem Auditieren vermittelt.

Die GDP-Schulung führt in die Good Distribution Practices (GDP) für die Pharmaindustrie ein. Grundlage ist die EU-Leitlinie 2013/C 343/01, deren Ziel es ist, entlang der gesamten Lieferkette sicherzustellen, dass die Qualität gewährleistet und die Arzneimittel unversehrt bleiben. Die Schulung richtet sich an Pharmahersteller und Großhändler, aber auch an Lagerdienstleister und Logistikunternehmen, die Pharmaprodukte herstellen, beschaffen, lagern, transportieren oder handeln. Vom Pharmahersteller bis zu den Apotheken sorgen sie dafür, dass die Produktqualität in der integrierten Lieferkette garantiert ist. Die Schulung vermittelt Ihnen die Grundprinzipien der GDP und ihre Anforderungen. Sie werden in die Lage versetzt, Schwachstellen zu erkennen, Lösungsansätze zu ermitteln und die Anforderungen der GDP im eigenen Betrieb umzusetzen.

The training refreshes essential GDP knowledge, informs you about current topics and regulatory updates, and provides a platform to share best practices and discuss operational challenges. Participants will also gain valuable insights from audits, inspections, and practical case studies.

As the world is moving faster than ever, technological developments have rapidly evolved and are redefining, among others, the way we live, learn, and teach. This expansive nature of the internet and technology demand new ways of adapting to this new virtual environment for all of us. This new world has given birth to a new form of studying that is both efficient and of global reach: eLearning.The ISO/IEC 27005 Risk Manager eLearning training course provides valuable information on risk management concepts and principles outlined by ISO/IEC 27005 and also ISO 31000. The training course provides participants with the necessary knowledge and skills to identify, evaluate, analyze, treat, and communicate information security risks based on ISO/IEC 27005. Furthermore, the training course provides an overview of other best risk assessment methods, such as OCTAVE, MEHARI, EBIOS, NIST, CRAMM, and Harmonized TRA.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO/IEC 27005 Provisional Risk ManagerPECB Certified ISO/IEC 27005 Risk ManagerEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and your final exam.If you have not received this within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationIn addition to the online videos of the training course, participants will be provided with the conventional training course material containing over 350 pages of explanatory information and practical examples.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 21 CPD (Continuing Professional Development) credits.In case candidates fail the exam, they can retake it within 12 months following the initial attempt for freeThe fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF) (AMF is not applicable for Foundation, Provisional and Transition Certification)

COURSE DESCRIPTIONThe objective of this course is to provide participants with an overview of the purpose and requirements of ISO 37001:2016.PRIOR KNOWLEDGEBefore starting this course, it is recommended that participants are involved in:• Management systems within their business, and have a basic understanding of the Plan-Do-Check-Act (PDCA) cycle• Anti-bribery management within their business and know the anti-bribery policiesCOURSE CONTENT• Introduction to Anti Bribery Management Systems (ABMS)• History of ABMS• Fundamental principles of ABMS• Overview, structure and clauses of ISO 37001:2016• Corporate governance and use of best practices• Assessment to evaluate learningCompletion criteria: learners will be required to complete the entire course and gain a pass mark of 80% or more in the final assessment. Upon successful completion learners will be able to download a certificate of completion.You will be granted 12 months access to this course, effective from the date of purchase.

As the world is moving faster than ever, technological developments have rapidly evolved and are redefining, among others, the way we live, learn, and teach. This expansive nature of the internet and technology demand new ways of adapting to this new virtual environment for all of us. As such, the use of new and more efficient learning methods is continuing to grow across a broad range of industries. In this new world, eLearning has become the tool of choice for learning and teaching worldwide.The ISO 31000 Risk Manager eLearning training course helps you acquire the knowledge and ability to integrate the risk management guidelines of ISO 31000 in an organization. It provides information with regard to the risk management principles and their application, as well as the core elements of the risk management framework and steps for a risk management process.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO 31000 Provisional Risk ManagerPECB Certified ISO 31000 Risk ManagerEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and your final exam.If you have not received this within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationIn addition to the online videos of the training course, participants will be provided with the conventional training course material containing over 300 pages of explanatory information and practical examples.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 21 CPD (Continuing Professional Development) credits.In case candidates fail the exam, they can retake it within 12 months following the initial attempt for freePrerequisitesA fundamental understanding of ISO 31000 and comprehensive knowledge of risk management.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF) (AMF is not applicable for Foundation, Provisional and Transition Certification)

The purpose of this course is to provide the learner with an overview of the purpose and requirements of risk management and risk-based thinking which can be applied to any management system.Completion criteria: learners will be required to complete the entire course and gain a pass mark of 80% or more in the final assessment.   Upon successful completion learners will be able to download a certificate of completion.You will be granted 12 months access to this course, effective from the date of purchase.

SGS has developed this course to benefit clients wishing to gain knowledge of specific automotive cybersecurity modules. COURSE CONTENTIntroduction to automotive cybersecurityISO/SAE 21434 standard overviewCybersecurity in product developmentImplementation of best practicesPRIOR KNOWLEDGENo prior experience with ISO/SAE 21434 is required, though a basic understanding of automotive systems and general cybersecurity concepts is beneficial.COURSE CERTIFICATION On completion of this course: The SGS certificate is available to download once you have achieved a pass mark of 80% or more in the final assessment which completes this course. You have 12 months access to this course, effective from the date of purchase.

This training aims to familiarise learners with the new EUDR regulation ensuring supply chain accountability for forest protection and safeguarding our planet for the future.