Unlimited number of participants; recordings to download - not only for one-time streaming; unlimited use for further company-internal training purposes; individual and free time management; some available immediately.
Your daily activities are increasingly determined by operating in interdisciplinary teams. Your company needs fewer consultants for its success, but more strong personalities in its own ranks. We want to strengthen your competence and that of your employees. We see our task in supporting you in the horizontal transfer of knowledge in your company with the aim of broadening the common knowledge base. Joint learning strengthens the feeling of togetherness and communication in any company and thus guarantees mutual success. Shared successes motivate teams and bring together the competencies of all team members. Quality is not a goal, but a process that requires active, conscious action and must be worked out strategically.
Successful in-house training requires customized concepts. You can adopt existing topics from our generic events, adapt them individually or completely redesign them. Even smaller companies can benefit from a customized in-house seminar, as this type of training is not dependent on the size of the company or the target group. The training courses take place at the company's own premises. The training content can be individually tailored. The company determines the group composition and number of participants as well as the training content. Face-to-face or online.
- Definition of "Regulatory Starting Materials"
- Regulatory requirements for different types of impurities (residual solvents, metal impurities, genotoxic impurities, contaminants)
- GMP regulations
- Analytical procedure validation in pharmaceutical analysis
- Overview of pharmacopoeial requirements
- (Annual) overview of important innovations in the CMC and GMP environment
- GMP: regulations, implementation and application in the company
- Marketing Authorization for Non-Certifiers: Regulations, Implementation and Practical Knowledge for Human and/or Veterinary Medicinal Products
- The quality dossier for medicinal products for human use in the EU
- The Quality Dossier for Medicinal Products for Human Use in the EU - Focus on Phytopharmaceuticals
- "Good Chromatography Practice"
- Data integrity requirements
- Change Control
- Regulatory Compliance
- Specifications for active pharmaceutical ingredients, excipients, finished products and packaging materials
- Stability testing for active pharmaceutical ingredients and finished products in Europe
- Pharmaceutical Development
- Process validation in pharmaceutical manufacturing
- Cleaning validation in pharmaceutical manufacturing
- Qualification in analytical laboratory
- Analytical process transfer
- Drug release studies
- Stability studies
- Special Topics Stability Studies
- Requirements for drug release studies
- (Statistical) evaluation of CMC data
- Reference standards in pharmaceutical analysis
- Requirements for plastic primary packaging materials for active pharmaceutical ingredients and finished products
- The European Pharmacopoeia (also as update)
- The United States Pharmacopoeia (USP) (also as update)
- Special topics of herbal active ingredients and phytopharmaceuticals (development, process validation, specifications, contaminants)
- Differentiation of herbal products (medicinal products | medical devices | food supplements)
- Cannabis (GMP requirements, manufacturing and marketability)
- "Outsourcing" in the context of manufacturing and testing of medicinal products
- Processes, specifications and success factors for drug development
- Development of medical devices and pharmaceuticals in Germany and Europe Success factors and stumbling blocks
- Combination products: Pharmaceutical law requirements for the quality of the medicinal ingredient for combinations between medical devices and medicinal products
Please ask us for the topic or subject area you require, we will send you a complete list of possible contents from which you can compile your program.
If there is a need for additional topics on your part, please contact us. We will be happy to work out a training course that is specifically tailored to your needs.