Quality management in the medical device industry and in the area of drug approval (regulatory affairs)
Free of cost
by funding
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Certificates: Certificate "Quality management in the medical device industry"
Certificate "Quality management in the area of drug approval (regulatory affairs)" -
Examination: Practical project work with final presentations
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Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 8 Weeks
QM in the medical device industry
Introduction to general quality management (approx. 1 day)
Basics of QM
Q-methods and Q-tools
QM - Medical devices ISO 13485 (approx. 2 days)
Structure, scope, area of application of ISO 13485
Relationship between MDR/IVDR and ISO 13485
ISO 13485 in the context of the requirements of 21 CFR Part 820
Requirements for management systems (approx. 3 days)
Management standard ISO 9001:2015
Provision and management of resources
Basics in the area of measurements and tests
Requirements for measuring equipment management for medical devices/diagnostics
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Process-oriented QM (approx. 4 days)
Meaning of process, process orientation, process description and process validation
Corrective and Preventive Actions (CAPA process)
Continuous improvement process (CIP)
Monitoring products on the market: defect and complaint management, postmarket surveillance (PMS and PMCF), reporting procedures and complaint handling
Communication with the authorities and notified bodies: Feedback and reporting
Documentation systems (approx. 3 days)
Basics of general QM documentation, document control and archiving
Validation parameters (IQ, OQ, PQ)
Summary Technical Documentation: STED
Risk management (approx. 2 days)
Importance of the risk management standard ISO 14971
Product and process risks
Risk areas, typical product risks
Audits and inspections (approx. 2 days)
Application of EN ISO 13485
Certifiers or the responsible authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
Auditor duties, audit planning and implementation
Audits taking into account the implementation of legal and technical requirements
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Regulatory Affairs: Quality management in the area of drug approval
Introduction to pharmaceutical law (approx. 3 days)
Current legal framework for medicinal products (AMG, EU Regulation 726/2004 with reference to Directive 2001/83/EC)
Life cycle management
Pharmacovigilance
Paediatric Regulation
Regulatory authorities and institutions involved (approx. 2 days)
Federal Institute for Drugs and Medical Devices (BfArM)
Paul Ehrlich Institute (PEI)
Institute for Quality and Efficiency in Health Care (IQWiG)
Federal Joint Committee (G-BA)
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
European Medicines Agency European Medicines Agency (EMA)Marketing authorization dossier - Common Technical Document (CTD) (approx. 5 days)
Administrative Information
Overview and summaries
Pharmaceutical quality
Preclinical studies
Clinical studies
Preparation of an application for admission (approx. 2 days)
Medical Writing
Guidelines
Guidelines in the regulatory area
Notice to Applicants (NtA)
Scientific Advice (SA)
Types of approval (approx. 2 days)
National admission procedure
The central admission procedure
Mutual Recognition Procedure (MRP)
Decentralized procedure
Generics approvals
Authorization of biosimilars
Medicinal products for rare diseases
Standard approvals
Life cycle of a medicinal product after market launch (approx. 3 days)
The spontaneous reporting system
The Periodic Safety Update Report (PSUR)
The Risk Management Plan (RMP)
Extension of the marketing authorization (renewal)
Project work (approx. 3 days)
To consolidate the content learned
Final presentation of the project results
Changes are possible. The course content is updated regularly.
After the course, you will be familiar with the regulations, standards and certifications for medical devices and will be able to contribute to the implementation of EN ISO 13485:2021-12.
Furthermore, you are familiar with the guidelines, laws and standards relating to the approval of medicinal products. You are familiar with the requirements and procedures of the approval process and are able to take responsibility for the global approval of medicinal products.
The course is aimed at people with a degree in (veterinary) medicine, biology, chemistry, pharmacy or a natural science course.
In order for a medical device to be sold on the German and European market, medical device regulations must be complied with during production. Specialists who are familiar with the production process and the applicable quality standards are in high demand in the medical device industry. In addition, such knowledge also helps the pharmaceutical industry to better understand the regulatory requirements at the interface between the pharmaceutical and medical technology industries.
Employees in Regulatory Affairs Management in drug approval have a wide range of responsibilities: they are not only responsible for the support of a drug beyond its approval, but also coordinate all departments involved in its development and marketing to ensure the safety, quality and efficacy of the product as well as compliance with country-specific approval standards. Regulatory affairs management is essential for drug approval, which is why additional knowledge in this area is in high demand, especially in the pharmaceutical industry.
Your meaningful certificate provides a detailed insight into the qualifications you have acquired and improves your career prospects.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).