-
Certificates: GMP - Good Manufacturing Practice" certificate
Certificate "Quality management in the area of drug approval (regulatory affairs)" -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
-
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.)
-
Language of Instruction: German
-
Duration: 8 Weeks
GMP - Good Manufacturing Practice
Introduction to GMP (approx. 2 days)
EU GMP guidelines, AMG, AMWHV
Authorities, drug approvals, marketing authorization
Key persons
FDA, CFR 21
International regulations
AI in the pharmaceutical environment
SOP system (approx. 2.5 days)
Requirements for SOPs
Structure of SOPs
Document control and version management
Training system (approx. 1.5 days)
Employee qualification
Training planning and documentation
Effectiveness control
Deviation and CAPA management (approx. 2 days)
Deviations and CAPA
Requirements for deviation and CAPA management
Documentation of deviations
Error cause analysis
Corrective and preventive measures
CAPA process
AI-supported data analysis for root cause identification
Change management (change control) (approx. 1 day)
Requirements for change management
Notifiable changes, classification of changes
Risk management in the change process
Change management process
Validation and qualification (approx. 1.5 days)
Device, system and room qualification
Process, cleaning and method validation
Qualification and validation process
Qualification and validation documentation
Quality control (approx. 1 day)
Sampling and testing
stability
Dealing with OOS
Storage status
AI-supported evaluation of test data
Complaints management (approx. 0.5 days)
Complaints
Product recall
Audit management (approx. 0.5 days)
Audit types and audit process
Internal audit and FDA inspection
AI-supported data analysis for audit preparation
Supplier qualification (approx. 0.5 days)
Supplier qualification and evaluation
Review and trending (approx. 0.5 days)
Batch Record Review
Product Quality Review
Management Review
Industrial hygiene in the pharmaceutical industry (approx. 2 days)
Personnel hygiene
Hygiene requirements
Clothing and behavior
Production hygiene
Contamination prevention
Hygiene plans
Documentation (approx. 0.5 days)
GMP documentation and data integrity
AI-supported support for document review
Production rooms - clean rooms (approx. 1 day)
General requirements for production rooms
Requirements for premises including storage areas
Avoidance of cross-contamination
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Quality management in the area of drug approval (Regulatory Affairs)
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 this course, you will be familiar with the requirements of a GMP system, the applicable regulations and the central processes of pharmaceutical quality management. You will understand the basics of SOP systems, CAPA, change management, audit processes, documentation, quality control, industrial hygiene and cleanroom requirements and be able to classify relevant technical terms with confidence.
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.
GMP knowledge is indispensable in almost all areas of the production of pharmaceuticals and active ingredients, as well as cosmetics, food and animal feed. Your newly acquired knowledge will open up numerous new opportunities for you in these sectors.
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).