Abschluss einer SOTIF PRO – Personen-Qualifizierung

Die GDP-Schulung bietet eine umfassende Einführung in die Good Distribution Practices (GDP) für die Pharmaindustrie. Grundlage ist die EU-Leitlinie 2013/C 343/01, die darauf abzielt die Qualität und Unversehrtheit von Arzneimitteln entlang der gesamten Lieferkette zu gewährleisten. Sie richtet sich an Pharmahersteller, Großhändler, Lagerdienstleister und Logistikunternehmen, die mit der Herstellung, Beschaffung, Lagerung sowie dem Transport oder Handel von Pharmaprodukten befasst sind. Vom Pharmahersteller bis zu den Apotheken sorgen sie dafür, dass die Produktqualität in der integrierten Lieferkette garantiert ist. In dieser Schulung lernen Sie die Grundprinzipien und Anforderungen der GDP kennen. Sie werden befähigt, Schwachstellen zu erkennen, Lösungsansätze zu ermitteln und die GDP-Anforderungen in Ihrem Betrieb umzusetzen. Auf Anforderungen in Audits wird ebenfalls Bezug genommen.Beachten Sie auch unser GDP Refresher Training – ideal als jährliches Update!

Social audits are becoming increasingly important, and companies must take social responsibility. This training will provide you with all the basics on the topic of social audits - their definition, objectives, content, etc. The training module also serves as preparation for SOC - Module 2, Internal Auditor in social systems.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation are intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires domestic and international food facilities (i.e., food manufactures, processors, packers and distributors) that are registered with the FDA to develop and implement a Food Safety Plan that complies with the requirements and that certain activities must be completed by a "Preventive Controls Qualified Individual" (PCQI). The PCQI course for human food was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the only "standardized curriculum" recognized by the Food and Drucg Administration (FDA).The Food Safety Preventive Controls Alliance is a broad-based public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act. This 3-days course will help the participants to meet the FDA’s PCQI training requirements, understand the requirements of the Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food, and develop and implement the Food Safety Plan according to the Preventive Controls Human Food regulation (21CFR Part 117).

This course is certified by the Chartered Quality Institute (CQI) and International Register of Certificated Auditors (IRCA). CQI and IRCA Course Certification Number 2608 – PR 356.The aim of this course is to provide learners with the knowledge and skills required to perform first, second and third-party audits of Occupational Health & Safety Management Systems (OH&S) against ISO 45001:2018, in accordance with ISO 19011 and ISO 17021-1, as appropriate.Course certificationOn completion of this course:Learners who pass both the examination and continuous assessment will be issued with a “Certificate of Achievement” that satisfies the formal training for an individual seeking certification as a CQI and IRCA Auditor. The “Certificate of Achievement” is valid for a period of five years from the date of the last day of the examination for certifying as an Auditor/Lead Auditor with the CQI and IRCA.Learners who do not pass the continuous assessment and have been in attendance for the full duration of the course will be issued with a “Certificate of Attendance”.Learners who fail the written examination and pass the continuous assessment will receive a “Certificate of Attendance” and will be allowed to re-sit the examination within 12 months of the end date of the first examination.Recommended prior knowledgeIt is recommended that learners have knowledge of the following:OH&S management principles and concepts:The concept of OH&S sustainable development whereby an organisation must ensure that actions of today do not degrade the environment of the future.The purpose of an initial review as the basis for establishing an OH&S management system where none currently exists.Evaluation of activities, products and services to establish the risks and hazards associated with normal operating conditions and abnormal conditions, such as start-up and shutdown, and emergency situations and accidents.Consideration of risks and hazards in respect of:Workplace locations and activities.Work-related activities carried out away from the normal place of work or base.Employees, visitors and other interested parties in areas where the organisation has control and influence over health and safety.Vulnerable individuals within the workplace or control of the organisation.OH&S legislation and how legal compliance forms part of an OH&S management system.A good appreciation of typical methods of evaluation of risks and hazards and their mitigation, and the identification of improvements (e.g. risk assessments and method statements).Knowledge of the requirements of ISO 45001:2018, which may be gained by completing a CQI and IRCA certified OH&S Foundation Training Course or equivalent.Learners for this conversion course should have completed a full 5-day IRCA certified Auditor/Lead Auditor course in another scheme prior to attending this course. This is a pre-requisite requirement to register on the CQI and IRCA Auditor certification scheme.

An occupational health and safety management system creates a high level of safety in the company. It contributes significantly to making processes more effective, minimizing risks and managing a business successfully.   In this training, you will learn to interpret the requirements of the standard and relate them to occupational health and safety regulations. The contents of the seminar will be deepened with the help of practical case studies. 

Die internationale Norm ISO 22000 ist ein weltweiter Standard für Managementsysteme zur Lebensmittelsicherheit und gilt für alle Organisationen, die direkt oder indirekt an der Wertschöpfungskette in der Lebensmittelherstellung beteiligt sind.In diesem eintägigen Training erhalten Sie einen Überblick zu den Inhalten der ISO 22000:2018 und Neuerungen im Vergleich zur Version ISO 22000:2005.

We offer a 10% "Early Bird" discount to all registrations made 6 weeks before training starts. Online trainings are not includedWe qualify you or your employees to work with functional safety. To this end, we at SGS-TÜV Saar have developed a two-stage qualification programme. Upon successful completion of the qualification, the SGS-TÜV Saar seal certifies that the graduate is an expert in functional safety.Our training courses take place with a minimum of three registered participants. You will receive confirmation of your registration approximately four weeks before the training course. Online training courses take place via MS Teams.Recording and duplicating training courses is not permitted. We reserve the right to take legal action in the event of non-compliance.

We offer a 10% "Early Bird" discount to all registrations made 6 weeks before training starts. Online trainings are not includedWe qualify you or your employees to work with safe artificial inteligence in semicondictors.  After a successfull completion, the SGS-TÜV Saar seal confirms that the graduate is an AI professional in the development of functional safe semiconductors.Our training courses take place with a minimum of three registered participants. You will receive confirmation of your registration approximately four weeks before the training course begins. Online training courses take place via MS Teams. Recording and duplicating training courses is not permitted. We reserve the right to take legal action in the event of non-compliance.

We offer a 10% "Early Bird" discount to all registrations made 6 weeks before training starts. Online trainings are not includedISO 25119 is a complex set of standards and hard to comprehend for beginners in the field of Functional Safety. This training module initially introduces the basics of Functional Safety and then explains the core statements of the standards.Our training courses take place with a minimum of three registered participants. You will receive confirmation of your registration approximately four weeks before the training course begins. Online training courses take place via MS Teams.Recording and duplicating training courses is not permitted. We reserve the right to take legal action in the event of non-compliance.

We offer a 10% "Early Bird" discount to all registrations made 6 weeks before training starts. Online trainings are not includedThe more complex the technology, the more experts are needed for functional safety in the industrial sector and in agricultural and forestry management. But the question is, who is an expert in functional safety? ISO 25119 does not answer the question. On the one hand, it is required that only experts assess or manage functional safety, and on the other, they do not set out the conditions under which someone is considered an expert.Our training courses take place with a minimum of three registered participants. You will receive confirmation of your registration approximately four weeks before the training course begins. Online training courses take place via MS Teams.Recording and duplicating training courses is not permitted. We reserve the right to take legal action in the event of non-compliance.